Devices, systems, and methods for attaching soft tissue to bone tissue

ABSTRACT

A suture anchoring device for fixing a soft tissue to a bone tissue is disclosed that enables the exchange of sutures between anchors after implantation. The suture anchoring device may include a body that is inserted into the bone tissue, a suture exchange fitting situation within a passage formed within the body, and one or more pre-loaded sutures looped through the suture exchange fitting and projecting proximally from a proximal opening formed in the body. Surgical kits and surgical methods for performing various repair procedures using one or more suture anchoring device are also disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation-in-part of PCT Application No.PCT/US2013/053524, with an international filing date of Aug. 3, 2013,entitled “SUTURE ANCHOR DEVICE AND METHODS OF USE,” and is herebyincorporated by reference in its entirety into the present application.PCT Application No. PCT/US2013/053524 claims priority to U.S. patentapplication Ser. No. 13/566,845 which was filed Aug. 3, 2012 and to U.S.provisional patent application 61/817,841 which was filed Apr. 30, 2013,each of which is hereby incorporated in its entirety into the presentapplication.

The present application also claims priority to U.S. provisional patentapplication No. 62/093,827 filed Dec. 18, 2014 entitled “DEVICES,SYSTEMS, AND METHODS FOR ATTACHING SOFT TISSUE TO BONE TISSUE;” U.S.provisional patent application No. 62/000,379, which was filed May 19,2014, entitled “DOUBLE-LOOPED SUTURE;” and U.S. provisional patentapplication 61/949,485, which was filed Mar. 7, 2014, entitled“DOUBLE-LOOPED SUTURE.” All three provisional applications are herebyincorporated by reference in their entirety into the presentapplication.

FIELD OF THE INVENTION

The present invention generally relates to medical devices and tosurgical implements. More particularly, preferred embodiments of theinvention relate to suture anchor devices and methods for using thesame.

BACKGROUND

Soft tissue, such as tendons or ligaments, is typically displaced fromits usual position in relation to the bone due to injury such asrupturing or tearing. Rotator cuffs, elbows, knees, ankles, and otherjoints are particularly prone to this type of injury. Injuries can betreated by attaching the soft tissue to the bone. Attaching soft tissueto bone may make use of suture anchors. Generally, a bone anchor withpre-loaded sutures is deployed into bone by inserting the anchor into anopening drilled into the bone. The pre-loaded sutures are used to attachthe soft tissue to the bone by suture fixation techniques such asknot-tying, or by insertion of the suture into a knotless anchor forfixation.

Surgical anchor repairs suffer risk of biomechanical failure. Reportedfailures include suture cutting through bone tunnels, suture breakage,knot slippage, suture anchor pull out, and soft tissue failure at thesuture-tendon junction. There is a need for a suture anchor device andmethod of use that will lower the risk of such biomechanical failures.

SUMMARY OF THE INVENTION

In one aspect, a tissue anchor is provided that includes a body and aflexible elongated element. The body may include a proximal end, adistal end opposite the proximal end, a proximal opening at the proximalend, a distal opening at the distal end, and a passage extendinglongitudinally through the body between the proximal and distalopenings. The flexible elongated element may at least contribute to thedefining of an aperture that opens in a direction substantiallyperpendicular to a longitudinal axis of the passage. The flexibleelongated element may be secured to the body at first and secondspaced-apart locations to facilitate the aperture being maintained in anopen condition. The first and second spaced-apart locations may includea first side of the passage and a second side of the passage oppositethe first side of the passage. The flexible elongated element may besecured to the each side of the passage via a ring, hook or loop. Thebody may further include a distal tip that may be at least one ofreceived or configured to be received in the distal opening. The firstand second spaced-apart locations may include a first side of the distaltip and a second side of the distal tip opposite the first side of thedistal tip. The body may further include a distal tip that may be atleast one of received or configured to be received in the distalopening. The flexible elongated element may include a first tail and asecond tail spaced-apart from the first tail by the first tail and thesecond tail respectively intersecting the distal tip at the first andsecond spaced-apart locations thereby facilitating the aperture beingmaintained in the open condition. When the distal tip is received in thedistal opening, the aperture may be located in the passage proximal thedistal tip. The distal tip may include a molded material; a distalregion of the first tail and a distal region of the second tail may bemolded into the molded material at the first and second spaced-apartlocations. The distal tip may be configured such that implantationforces exerted on the distal tip may enhance the extent to which thedistal tip may be received in the distal opening. The first and secondspaced-apart locations respectively may include first and secondspaced-apart channels in the distal tip, and a distal region of thefirst tail and a distal region of the second tail may be respectivelylocated in the first and second spaced-apart channels. The firstspaced-apart channel may include a groove defined in an outer surface ofthe distal tip and the distal region of the first tail may extendthrough the groove, which may open against an inner wall surfacedefining the passage when the distal tip is received in the distalopening. The first spaced-apart channel may include a lumen defined inthe distal tip and the distal region of the first tail may extendthrough the lumen. The first and second tails may be distally joinedtogether via a knot. The knot may be coated or impregnated with apolymer, epoxy or adhesive. The first and second tails may be part of acontinuous loop of the flexible elongated element. The first and secondtails may extend into each other in a continuous manner. The first andsecond tails may be distally joined together via a joining memberextending about the at least portions of the first and second tails. Thejoining member may be at least one of crimped or molded onto the firstand second tails. The distal tip may include a distal recess in whichthe joining member may be seated. The distal tip may include a proximalshaft opposite the distal recess, the distal tip being received in thedistal opening on account of the proximal shaft being received in thedistal opening and residing in the passage. The proximal shaft may forman interference fit with at least one of the distal opening or thepassage. The first and second spaced-apart channels may extendlongitudinally along the proximal shaft. The aperture may be definedbetween the flexible elongated element and a proximal end of theproximal shaft of the distal tip. A maximum height of the aperture in anon-deflected state and extending parallel to the longitudinal axis ofthe passage may be defined between the flexible elongated element and aproximal end of the distal tip. The maximum height of the aperture maybe between a height of the proximal end of the tissue anchor and aheight of the proximal end of the body plus a thickness of a softtissue. The soft tissue may be proximal to the proximal end of the body.A maximum width of the aperture in a non-deflected state may be definedbetween the first and second spaced-apart locations, and the maximumwidth of the aperture may be approximately the maximum width of thepassage. The maximum width of the aperture may extend perpendicular tothe longitudinal axis of the passage. A most proximal extent of theflexible elongated element in a non-deflected state may be recesseddistally within the passage from the proximal opening up toapproximately a thickness of a suture mass to be passed through theaperture. The proximal opening may be configured to interface with aninsertion tool. The flexible elongated element may include a suture. Thesuture may be a braided suture formed of a material that may includepolyethylene. The material may further include a thickness of betweenapproximately 0.008″ and approximately 0.045″. The suture may be atleast one of heat treated, coated or impregnated to at least one ofstiffen or shape the suture. The flexible elongated element may includea wire or monofilament. The flexible elongated element may extendthrough a sheath. The flexible elongated element may extend along aU-shaped channel member. A segment of polymer or metal may extendthrough a lumen of the flexible elongated element. A loop may encircle aportion of the distal tip and the loop may include the flexibleelongated element. The aperture may be defined between the flexibleelongated element and a proximal end of the distal tip. The loop mayfurther include a joining member joining together the first and secondtails of the flexible elongated element. The joining member may bereceived in a distal recess of the distal tip.

In this one aspect, the tissue anchor may be a result of an assemblyprocess. The assembly process may include: a) assembling a tip assemblyby causing a loop to encircle a portion of the distal tip; and b)causing the tip assembly to be received in the distal opening of thebody. The loop may include the flexible elongated element. The loop mayfurther include a joining member joining together the first and secondtails of the flexible elongated element, and the joining member may bereceived in a distal recess of the distal tip as part of assembling thetip assembly.

In this one aspect, the body may further include a thread helicallyextending about an exterior of the body. The thread may include a doublehelix thread; the double helix thread may include two distinct threadsoffset approximately 180 degrees from each other. The aperture may havea minimum width to height ratio of three to one and a maximum width toheight ratio of one to ten. The flexible elongated element may beconfigured to flex in a twisting rotation manner such that the aperturecan accommodate different suture exchange attack angles. The flexibleelongated element may be configured to flex in a twisting rotationmanner such that a direction in which the aperture opens when theflexible elongated element is at maximum twisted rotation may be betweenapproximately 90 degrees and approximately 360 degrees from thedirection in which the aperture opens when the flexible elongatedelement is in a non-deflected state. The flexible elongated element maybe configured to maintain the aperture sufficiently open to accommodatesuture exchange despite being at the maximum twisted rotation. Theflexible elongated element may be configured to flex in a twistingrotation manner such that the aperture has no angles that are tighterthan approximately 90 degrees when the flexible elongated element is ata twisted rotation of up to approximately 90 degrees from the directionin which the aperture opens when the flexible elongated element is in anon-deflected state. The aperture may be configured to accommodate aminimum mass throughput of 4 sutures.

In another aspect, a surgical kit is provided that may include: thetissue anchor described herein, a suture, and instructions. The body ofthe tissue anchor may further include a distal tip that may be at leastone of received or configured to be received in the distal opening. Theflexible elongated element may include a first tail and a second tailspaced-apart from the first tail by the first tail and the second tailrespectively intersecting the distal tip at the first and secondspaced-apart locations thereby facilitating the aperture beingmaintained in the open condition. The suture may include a first end anda second end opposite the first end. The instructions may provide that,with the suture first extending through the aperture, the distal tip maybe caused to be received in the distal opening such that the suture mayextend through the passage and out the proximal opening such that thefirst and second ends of the suture are proximal the proximal opening.The suture may further include a loop at at least one of the first endor the second end of the suture. The loop may be the result of abifurcation of the suture or the loop may be a result of the suturebeing folded back on itself and adhered to itself.

In this other aspect, the surgical kit may further include a deliverydevice. The delivery device may include a distal end, a proximal endopposite the distal end, and a lumen extending between the distal andproximal ends of the delivery device. The distal end of the deliverydevice may include a feature for coupling with and transmitting a torqueto the proximal end of the body. The instructions may further providethat, once the distal tip is received in the distal opening such thatthe suture extends through the passage and out the proximal opening suchthat the first and second ends of the suture are proximal the proximalopening, the suture may be further caused to extend through the lumensuch that the first and second ends of the suture extend from theproximal end of the delivery device and the distal end of the deliverydevice may be engaged with the proximal end of the body. Theinstructions may be provided via at least one of: on packaging enclosingat least some of the surgical kit; in packaging enclosing at least someof the surgical kit; accompanying the surgical kit; an electroniccommunication; or an internet website.

In another additional aspect, a method of anchoring soft tissue to bonevia a first tissue anchor including a body including a proximal opening,a distal opening, a passage extending between the proximal and distalopenings, and a distal tip configured to be received in the distalopening is provided. The distal tip may be loaded with a first suturesuch that the first suture extends through an aperture of the distaltip. In this other additional aspect, the method may include: causingthe distal tip loaded with the first suture to be received in the distalopening of the body such that the first suture extends through thepassage of the body and out the proximal opening such that the first andsecond ends of the first suture are proximal the proximal opening. Oncethe distal tip is received in the distal opening such that the firstsuture extends through the passage and out the proximal opening suchthat the first and second ends of the first suture are proximal theproximal opening, the first suture may be further caused to extendthrough a lumen of a delivery device such that the first and second endsof the first suture extend from a proximal end of the delivery deviceand a distal end of the delivery device is engaged with a proximal endof the body. The lumen may extend between a distal end of the deliverydevice and the proximal end of the delivery device. The method mayfurther include using the delivery device to torque the first tissueanchor into the bone. The method may further include implanting thefirst tissue anchor into the bone with the suture loaded distal tipreceived in the distal opening. The method may further include: a)extending the first and second ends of the first suture through the softtissue; b) after step a), causing a second suture to extend through aloop defined in the first suture near the first end of the first sutureor between the first and second ends of the first suture; and c) afterstep b), pulling on the second end of the first suture to draw thesecond suture through the soft tissue and down into the implanted firsttissue anchor and through the aperture such that the second sutureextends through the passage of the body and out the proximal openingsuch that first and second ends of the second suture are proximal theproximal opening and extend through the soft tissue. The second suturemay extend through the soft tissue from a second tissue anchor implantedin the bone prior to being caused to pass again through the soft tissueat another location and down into the first tissue anchor as recited instep c). The second suture at the completion of step c) may extend fromthe first end of the second suture through the soft tissue, into and outof the implanted second tissue anchor, through the soft tissue, backinto the soft tissue, into and out of the implanted first tissue anchor,and through the soft tissue to the second end of the second suture. Themethod may further include: a) causing a second suture to extend througha loop defined in the first suture near the first end of the firstsuture or between the first and second ends of the first suture; b)after step a), pulling on the second end of the first suture to draw thesecond suture down into the implanted first tissue anchor and throughthe aperture such that the second suture extends through the passage ofthe body and out the proximal opening such that first and second ends ofthe second suture are proximal the proximal opening; and c) after stepb) extending the first and second ends of the second suture through thesoft tissue. The second suture may extend from a second tissue anchorimplanted in the bone prior to being caused to pass down into the firsttissue anchor as recited in step b). The second suture at the completionof step c) may extend from the first end of the second suture throughthe soft tissue, into and out of the implanted second tissue anchor,through the soft tissue, back into the soft tissue, into and out of theimplanted first tissue anchor, and through the soft tissue to the secondend of the second suture.

While multiple embodiments are disclosed, still other embodiments of thepresent disclosure will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the disclosure. As will be realized, theinvention is capable of modifications in various aspects, all withoutdeparting from the spirit and scope of the present disclosure.Accordingly, the drawings and detailed description are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE FIGURES

The following figures describe various aspects of the disclosure.

FIG. 1 is a side view of a tissue anchor device.

FIG. 2 is a cross-sectional side view of a tissue anchor device.

FIG. 3 is a transparent side view of a tissue anchor device.

FIG. 4 is a top perspective view of a tissue anchor device.

FIG. 5 is a side view of a tissue anchor device with a suture exchangefitting at the proximal end of the body.

FIG. 6 is a perspective cutaway view of a single-piece tissue anchordevice with a suture exchange fitting and sutures.

FIG. 7 is an exploded view of a tissue anchor device.

FIG. 8 is a cross-sectional side view of a tissue anchor device.

FIG. 9 is a side view of a tissue anchor device with a separate distaltip.

FIG. 10 is a side view of a suture exchange fitting in an openedconfiguration.

FIG. 11 is a side view of a suture exchange fitting in a collapsedconfiguration.

FIG. 12 is a side view of a distal end and a twisted exchange ring of asuture exchange fitting.

FIG. 13 is a top view of a distal end and a twisted exchange ring of asuture exchange fitting.

FIG. 14 is a side view of a distal end and a suture exchange fittingwith a short exchange ring.

FIG. 15 is a side view of a distal end and a suture exchange fittingwith a long exchange ring.

FIG. 16 is a side view of a suture exchange fitting in an openedconfiguration with several sutures within the exchange ring.

FIG. 17 is a cross-sectional side view of a tissue anchor device withsupport loops attached to the inner wall defining the passage.

FIG. 18 is a top perspective view of a distal tip with a first channelat a first side and a second channel at a second side of the distal tip.

FIG. 19 is a cross-sectional side view of a tissue anchor device with anexchange ring formed from a single flexible strand with opposed endssecured between the distal end of the body and the proximal end of thedistal tip.

FIG. 20 is a top perspective view of a distal tip with an exchange ringformed from a single flexible strand with opposed ends attached to aproximal face of the distal tip.

FIG. 21 is a cross-sectional side view of a tissue anchor device with anexchange ring formed from a single flexible strand reinforced by abraided sheath.

FIG. 22 is a cross-sectional side view of a tissue anchor device with anexchange ring formed from a single flexible strand reinforced by aU-shaped reinforcing element.

FIG. 23 is a cross-sectional side view of a tissue anchor device with anexchange ring formed from a single flexible strand reinforced by aninternal reinforcing element.

FIG. 24 is a side view of a U-shaped reinforcing element with a defectconfigured to enable the collapse of the exchange ring under acollapsing load.

FIG. 25 is a cross-sectional side view of a tissue anchor device with anexchange ring formed as a clip collapsed by an upward pull at greaterthan the collapsing force.

FIG. 26 is a cross-sectional side view of a tissue anchor device with anexchange ring formed as a clip collapsed by a downward push at greaterthan the collapsing force.

FIG. 27 is a cross-sectional side view of a tissue anchor device with anexchange ring formed as a rigid ring.

FIG. 28 is a cross-sectional side view of a tissue anchor device with anexchange ring formed as a bearing.

FIG. 29 is a cross-sectional side view of a tissue anchor device with anexchange ring formed as a disk-shaped bearing.

FIG. 30 is a cross-sectional side view of a tissue anchor device with anexchange ring formed as a ring with a transverse bar.

FIG. 31 is a top view of an exchange ring formed as a ring with atransverse bar.

FIG. 32 is a cross-sectional side view of a tissue anchor device with anexchange ring attached to a shaft with at least one bearing furtherattached to the shaft.

FIG. 33 is a perspective view of a distal tip with a proximal groove anda transverse bar forming a suture exchange fitting.

FIG. 34 is a perspective view of a body of a tissue anchor device with aproximal groove and a transverse bar forming a suture exchange fitting.

FIG. 35 is a cross-sectional side view of a tissue anchor device with anexchange ring attached to a ball.

FIG. 36 is a side view of a double-looped suture.

FIG. 37 is a side view of threading a first suture end through a secondsuture end during a suture exchange.

FIG. 38 is a side view of pulling a first suture end and attached secondsuture end during a suture exchange.

FIG. 39 is a top view of a suture loop formed from a bifurcation of asuture.

FIG. 40 is a block diagram summarizing elements of a surgical kit.

FIG. 41 is a flow chart summarizing a method of attaching a soft tissueto a bone using at least one tissue anchor device.

FIG. 42A, FIG. 42B, FIG. 42C, FIG. 42D, FIG. 42E, and FIG. 42F areschematic diagrams illustrating a single row repair using at least onetissue anchor device.

FIG. 43A, FIG. 43B, FIG. 43C, FIG. 43D, FIG. 43E, FIG. 43F, and FIG. 43Gare schematic diagrams illustrating a wide single row repair using atleast one tissue anchor device.

FIG. 44A, FIG. 44B, FIG. 44C, FIG. 44D, FIG. 44E, FIG. 44F, and FIG. 44Gare schematic diagrams illustrating a double row repair using at leastone single-loaded tissue anchor device.

FIG. 45A, FIG. 45B, FIG. 45C, FIG. 45D, FIG. 45E, FIG. 45F, and FIG. 45Gare schematic diagrams illustrating a double row repair using at leastone double-loaded tissue anchor device.

FIG. 46A, FIG. 46B, FIG. 46C, FIG. 46D, FIG. 46E, FIG. 46F, and FIG. 46Gare schematic diagrams illustrating a transosseous double row repairusing at least one double-loaded tissue anchor device.

FIG. 47A and FIG. 47B are schematic diagrams illustrating knotlessfixation methods for double-row repairs using at least one single-loadedor double-loaded tissue anchor device.

FIG. 48A, FIG. 48B, FIG. 48C, FIG. 48D, FIG. 48E, and FIG. 48F areschematic diagrams illustrating alternative double row repairs using atleast one single-loaded or double-loaded tissue anchor device.

FIG. 49A, FIG. 49B, FIG. 49C, FIG. 49D, FIG. 49E, FIG. 49F, FIG. 49G,FIG. 49H, FIG. 49I, and FIG. 48J are schematic diagrams illustrating alabrum repair using at least one single-loaded or double-loaded tissueanchor device.

FIG. 50A, FIG. 50B and FIG. 50C are cutaway views of a tissue anchordevice that includes a free-swiveling exchange ring.

Corresponding reference characters and labels indicate correspondingelements among the views of the drawings. The headings used in thefigures should not be interpreted to limit the scope of the claims.

DETAILED DESCRIPTION

In various aspects, a suture anchor device is provided herein for theattachment of soft tissues to bone. The suture anchor device may includea body which is inserted into bone tissue. The suture anchor device mayfurther include a suture exchange fitting situated within a passageformed in the body. The suture exchange fitting may enable one or morerepair sutures to be shuttled or exchanged through the suture anchordevice after the body has been implanted in bone. The sutures may belooped at one or both ends; each loop may reversibly trap an end of asecond suture, and the loop may pull the second suture through a sutureexchange fitting and/or a soft tissue during a suture exchange. Thesuture exchange fitting may be further configured to collapse ifsubjected to a sufficiently high suture pulling force, thereby lockingin any sutures present within the suture exchange fitting.

In various other aspects, a surgical kit is provided herein that mayinclude the suture anchor device, instructions for the use of the sutureanchor device, and an insertion tool or implanting the suture anchordevice in the bone tissue of a subject. In other additional aspects, amethod of anchoring a soft tissue to a bone using one or more tissueanchors is provided herein.

I. Tissue Anchor

One embodiment disclosed herein includes a tissue anchor that may beinserted into bone tissue to which a soft tissue is to be attached usingone or more sutures in a variety of suture patterns and/or arrangements.In various aspects, the tissue anchor may include one or more sutureloading features to enable the loading of one or more sutures into thetissue anchor device after deployment of the tissue anchor into the bonetissue. These one or more suture loading features may further enable theexchange of sutures between one or more additional tissue anchordeployed at other locations within the bone tissue. The one or moretissue anchors may provide robust anchor points for the secureattachment of an overlying soft tissue including, but not limited to, atendon or ligament to the underlying bone tissue. In various otheraspects, additional features of the tissue anchor as disclosed hereinmay facilitate suture exchange by reducing pull-through forces, mayinhibit anchor pullout, and/or may reduce the likelihood of suturefailure due to suture breakage, knot failure, and the like.

FIG. 1 is a side view of a tissue anchor 100 in an aspect. The tissueanchor 100 may include a body 102 with a proximal end 104 and a distalend 106 opposite to the proximal end 104. The proximal end 104 mayinclude a proximal opening 108 configured to receive one or more sutures110. In use, the distal end 106 of the tissue anchor 100 may be advancedinto a bone tissue (not shown) using an insertion tool (not shown)reversibly attached at the proximal end 104 of the tissue anchor 100. Inan aspect, the outer surface 112 of the tissue anchor 100 may include anexternal thread 114 to facilitate the insertion of the tissue anchor 100into the bone tissue.

FIG. 2 is a longitudinal cross-section of the tissue anchor 100 in anaspect. The one or more sutures 110 may be retained within a passage 116extending from the proximal opening 108 toward the distal end 106 alonga longitudinal axis 118 of the passage 116. Each suture 110 may passthrough an aperture 302 within a suture exchange fitting 300 situatedwithin the passage 116. In an aspect, the suture exchange fitting 300may be recessed distally within the passage 116 relative to the proximalopening 108. In another aspect, the passage 116 and aperture 302 may besized to permit a sliding motion of the one or more sutures 110 throughthe suture exchange fitting 300 to enable the exchange of suture in andout of the tissue anchor 100 and between two or more tissue anchor 100using a sufficiently low pulling force as described herein below.

The tissue anchor device 100, including various features of the body 102and suture exchange fitting 300 are described in detail herein below.

a. Body

Referring again to FIG. 1, the tissue anchor device 100 includes a body102 with a proximal end 104 and a distal end 106. In various aspects,the body 102 may be inserted into bone tissue to provide a robust anchorfor one or more sutures used to attach a soft tissue including, but notlimited to, a tendon or ligament to the bone tissue. As such, theexternal shape of the body 102 may be an elongated cylindrical profilesimilar to the external profile of known orthopedic fasteners including,but not limited to, bone screws.

In various aspects, the body 102 may have an outer diameter 124 rangingfrom about 2 mm to about 8 mm. The outer diameter 124 of the body 102may depend on any one or more factors including, but not limited to: theaccessible area of bone tissue within which the tissue anchor device 100is to be inserted, the desired anchoring strength of the tissue anchordevice 100, and the size and number of sutures to be anchored by thetissue anchor device 100. Larger outer diameters 124 may be selected forapplications requiring higher anchoring strength. Further, larger outerdiameters 124 may be selected for anchoring large diameter suturesand/or multiple sutures. In various other aspects, the outer diameter124 may range from about 2 mm to about 2.2 mm, from about 2.1 mm toabout 2.3 mm, from about 2.2 mm to about 2.4 mm, from about 2.3 mm toabout 2.5 mm, from about 2.4 mm to about 2.6 mm, from about 2.5 mm toabout 2.7 mm, from about 2.6 mm to about 2.8 mm, from about 2.7 mm toabout 2.9 mm, from about 2.8 mm to about 3.0 mm, from about 2.9 mm toabout 3.1 mm, from about 3.0 mm to about 3.2 mm, from about 3.1 mm toabout 3.3 mm, from about 3.2 mm to about 3.4 mm, from about 3.3 mm toabout 3.5 mm, from about 3.4 mm to about 3.8 mm, from about 3.6 mm toabout 4.0 mm, from about 3.8 mm to about 4.2 mm, from about 4 mm toabout 4.4 mm, from about 4.2 mm to about 4.6 mm, from about 4.4 mm toabout 4.8 mm, from about 4.6 mm to about 5.0 mm, from about 4.8 mm toabout 5.25 mm, from about 5.0 mm to about 5.5 mm, from about 5.25 mm toabout 5.75 mm, from about 5.5 mm to about 6.0 mm, from about 5.75 mm toabout 6.25 mm, from about 6.0 mm to about 6.5 mm, from about 6.25 mm toabout 6.75 mm, from about 6.5 mm to about 7.0 mm, from about 6.75 mm toabout 7.25 mm, from about 7 mm to about 7.5 mm, from about 7.25 mm toabout 7.75 mm, or from about 7.5 mm to about 8 mm.

In various other aspects, the body 102 may have a length 126 rangingfrom about 5 mm to about 50 mm. The length 126 may vary in proportion tothe outer diameter of the body 102. In various aspects, the ratio of thelength 126 to the outer diameter 124 of the body 102 may be 0.5:1, 1:1,1.5:1, 2:1, 2.5:1, 3:1, 3.5:1, 4:1, 4.5:1, 5:1, 6:1, 8:1, or 10:1. Invarious additional aspects, the length 126 of the body 102 may rangefrom about 5 mm to about 10 mm, from about 7.5 mm to about 12.5 mm, fromabout 10 mm to about 15 mm, from about 12.5 mm to about 17.5 mm, fromabout 15 mm to about 20 mm, from about 17.5 mm to about 22.5 mm, fromabout 20 mm to about 30 mm, from about 25 mm to about 35 mm, from about30 mm to about 40 mm, from about 35 mm to about 45 mm, and from about 40mm to about 50 mm.

1. External Threads

Referring again to FIG. 1, the body 102 may further include at least oneexternal feature to facilitate the implantation of the tissue anchordevice 100 into the bone tissue, and to enhance the anchor strength ofthe tissue anchor device 100 during long-term use. Any known externalfeature suitable for orthopedic anchor devices may be formed on the body102 including, but not limited to: one or more circumferential ringstypical of push-in suture anchors, and one or more threads 114 helicallyextending about an exterior of the body 102 as illustrated in FIG. 1. Inone aspect, the external feature may be one or more threads 114extending along at least a portion of the length 126 of the body 102.The one or more threads 114 may have any configuration suitable for usein an orthopedic anchoring device including, but not limited to: singlethreads with a constant thread pitch, single threads with a variablepitch, self-tapping threads, and double-helix threads.

FIG. 3 is a transparent side view of a tissue anchor device 100 with adouble helix thread in one aspect. As illustrated in FIG. 3, the doublehelix thread includes a first thread 114A and a second thread 114B; boththreads 114A/114B may start at the proximal end 104 oriented about 180°from one another. In this aspect, the double helix threads 114A/14B mayenable a relatively high thread density, which may enhance bone fixationof the tissue anchor device 100, while maintaining a relatively highthread pitch, which may reduce the number of turns associated withdriving the tissue anchor device 100 into the bone tissue. Compared to adouble helix thread, a single helix thread may have a lower thread pitchto enable an equivalent thread density, and as a result may drive thetissue anchor device 100 into the bone tissue with a higher number ofturns during implantation.

2. Distal End

Referring again to FIG. 1, the distal end 106 of the body 102 may beconfigured to facilitate the implantation of the tissue anchor device100. Referring again to FIG. 2, the distal end 106 of the body 102 mayfurther include a lead-in 130 in one aspect. The lead-in 130 may betapered at the distal end 106 and may further be non-threaded. Theprofile of the lead-in 130 may be any suitable profile including, butnot limited to: a conical profile, a spherical profile, a pointedprofile, and any other suitable profile.

In one aspect, the body 102 may be a solid body with no internalpassage, lumen, or the like. In this aspect, a suture exchange fitting300 may be formed in other configurations, such as an eyelet formed inthe solid body 102 for receiving multiple thicknesses or strands of asuture. In this aspect, the body 102 may include a suture exchangefitting 300 attached to the proximal end 104 of the body 102, asillustrated in FIG. 5. In other aspects, the suture exchange fitting 300may be attached at any other location on the solid body 102 withoutlimitation. In yet other aspects, the suture exchange fitting 300 mayinclude one or more bores (not shown) formed through the solid body 102at any location on the body 102 without limitation.

3. Interior Passage

In another aspect, illustrated in FIG. 2, the body 102 may furtherinclude an interior passage 116 extending from the proximal opening 108toward the distal end 106 for at least a portion of the length 126 ofthe body 102. In various aspects, the passage 116 may have an innerdiameter 128 ranging from about 1 mm to about 6 mm. The inner diameter128 may be selected to maintain a minimum material thickness throughoutthe body 102 to maintain the structural integrity of the tissue anchordevice 100 during implantation and long-term use. In addition, the innerdiameter may further be selected to provide sufficient space to exchangeone or more sutures 110 with suitably low pulling resistance and/or tomaintain a sufficiently large aperture 302 of the suture exchangefitting 300 for suture exchange.

In various aspects, the ratio of the inner diameter 128 to the outerdiameter 124 of the body 102 may be about 1:10, about 1:9, about 1:8,about 1:7, about 1:6, about 1:5, about 1:4, about 1:3, about 1:2, about1:1.5, and about 1:1.2. In various aspects, the passage 116 may have aninner diameter 128 ranging from about 1 mm to about 2 mm, from about 1.5mm to about 2.5 mm, from about 2 mm to about 3 mm, from about 2.5 mm toabout 3.5 mm, from about 3 mm to about 4 mm, from about 3.5 mm to about4.5 mm, from about 4 mm to about 5 mm, from about 4.5 mm to about 5.5mm, and from about 5 mm to about 6 mm.

In an aspect, the inner diameter 128 of the passage 116 may besufficiently large to accommodate the width and the minimum mass widthof the sutures 110 loaded into the tissue anchor device 100. The minimummass width of the sutures 110, as used herein, refers to the width ofdouble the number of sutures present in the tissue anchor device 100,and allows for the additional widths of any sutures that may beexchanged from an additional tissue anchor device 100. By way ofnon-limiting example, the mass width of the sutures 110 for a tripleloaded tissue anchor device 100 may be 3 sutures 110, each loopedthrough the aperture 302, for a total suture mass equal to thecollective width of six sutures 110. An exchanged suture would result inan additional suture 110 being exchanged or pulled through the aperture302, and this exchanged suture 110 may also fold over or otherwiserepresent a mass of double its single strand width during the sutureexchange.

As described in detail herein below, the suture exchange may involve apull of a first suture that is threaded through the aperture 302 and mayfurther involve linking to a second suture that is also threaded throughthe aperture 302; the first and second suture may each contribute twoends that extend proximally from the aperture 302 through the passage116, resulting in four lengths of suture occupying the passage 116during a suture exchange, because each of the sutures is folded withinthe body 102 of the tissue anchor device 100. In various other aspects,the inner diameter 128 of the body 102 may be sufficiently large toaccommodate the width and the minimum mass width of one (single loaded)#2 suture, 2 (double loaded) #2 sutures, or three (triple loaded) #2sutures, combined with the added width of an exchanged #2 suture from anearby anchor. In all cases, the minimum width must accommodate theloaded width and exchange width equal to twice the individual width of a#2 suture.

In various aspects, the inner diameter 128 of the passage 116 may besized to reduce the pulling friction as one or more sutures 110 arepulled through the aperture 302 within the passage 116. In otheraspects, the passage may further include additional features to reducepulling friction. In one aspect, the passage 116 may be configured toavoid the inclusion of potential pinch points and/or friction pointsthat may impede suture exchange, catch a suture during a sutureexchange, and/or otherwise reduce suture exchange efficiency. In onenon-limiting example, illustrated in FIG. 2, the inner wall 120 definingthe passage 116 may be formed as a continuously smooth surface with noabrupt transitions between regions of the passage 116 that may result insharp edges against which a suture 110 may rub. In another non-limitingexample, the proximal opening 108 may include a chamfer 136 to reducethe sharpness of the lip surrounding the proximal opening 108.

Referring again to FIG. 5, the suture exchange fitting 300 may protrudeproximally from the proximal end 104 of the body 102 in an aspect. Inthis one aspect, the passage 116 need not accommodate the sliding of oneor more sutures 110, because the aperture 302 is not situated within thepassage 116. In this aspect, the inner diameter 128 may be reduced toless than the width and/or the minimum mass width of two or more sutures110 within the body 102. However, this arrangement of the sutureexchange fitting 300 at the proximal end 104 of the body 102 may resultin contact between the aperture 302 and the soft tissue contacting thesurface of the bone above the proximal end 104 of the tissue anchordevice; this contact may lead to increased friction between the aperture302 and the one or more sutures 110 during a suture exchange, and/orirritation and/or inflammation of the soft tissue that may prolonghealing of the soft tissue. To reduce the contact between the aperture302 and the soft tissue, the body 102 may be sufficiently counter-sunkinto the bone tissue to situate the aperture 302 below the bone surface.However, the overlap between the bone anchor and the rigid cortical bonemay be reduced by this countersinking thereby reducing the overallfixation strength of the anchor.

4. Tool Fitting and Vent Holes

In various aspects, the proximal end 104 of the body 102 may beconfigured to engage one or more tools used to implant the tissue anchordevice 100 within the bone tissue. FIG. 4 is a top perspective view of abody 102 showing the proximal opening 108. In an aspect, the proximalopening may include a tool fitting 134 configured to receive a tool (notshown) used to insert the body 102 into the bone tissue. The toolfitting 134 may be configured to receive any suitable orthopedicinsertion tool including, but not limited to, a torsional driver, animpact tool such as a slap hammer or impact hammer, and any othersuitable tool. The tool fitting 134 may have any suitable profilecorresponding to an orthopedic anchor insertion tool including, but notlimited to: single-blade screwdriver, a cruciform driver, aPhillips-head screwdriver, a star-head driver, a hexagonal driver asillustrated in FIG. 4, and any other suitable tool fitting profile. Inanother aspect, the tool fitting 134 may include a chamfer 136 (see FIG.4), fillet or other feature at the entry point of the tool fitting 134to facilitate the insertion of the implantation tool into the proximalend 104 of the body 102.

Referring again to FIG. 1, the body 102 may further include additionalfeatures to enhance the healing of the bone tissue in the vicinity ofthe implanted tissue anchor device 100 and/or to enhance the adhesion orintegration of bone tissue into the external surface of the body 102. Inone aspect, the body 102 may include one or more vent holes 132extending from the exterior surface of the body 102 into the passage 116within the body 102. In this aspect, the one or more vent holes 132 mayfacilitate the migration of red blood cells and other cells andbiofluids into the body 102 and may further facilitate contact of thesecells and biofluids with the bottom surface of the soft tissue adjacentto the bone tissue, thereby promoting healing. In another aspect (notshown) the exterior surface of the body 102 may further include one ormore depressions including, but not limited to dimples, blind bores,and/or indentations. In this other aspect, the one or more depressionsmay enhance the contact area of the body 102 with the surrounding bonetissue. In addition, the one or more depressions may be filled with oneor more bioactive substances to promote healing of the bone tissue andoverlying soft tissue. Non-limiting examples of suitable bioactivesubstances include: anti-inflammatory compounds, antibiotics,immunosuppressant compounds, and/or tissue growth stimulants such asbone growth factor.

In various aspects, the body 102 may be formed using any suitablebiocompatible material of sufficient strength without limitation. Invarious aspects, any one or more known materials for orthopedicfasteners may be used to construct the body 102 including, but notlimited to: metals and alloys including stainless steel, titanium, andtitanium alloys, and biocompatible plastics and polymers such as PEEK.In one aspect, the body 102 may be constructed of a single material. Inanother aspect, the body 102 may be a composite structure composed oftwo or more materials.

b. Distal Tip

Referring to FIG. 6, the body 102 may be provided as a single segmentextending from the proximal end 104 to the distal end 106 in one aspect.In this aspect, the distal end 106 may include a distal opening 138through which a suture exchange fitting 300 may be inserted. In otheraspects, the tissue anchor device 100 may further include a distal tip200 in addition to the body 102. In these other aspects, the distal tip200 may be received and/or may be configured to be received in thedistal opening 138 of the body 102. The two-piece design of these otheraspects may facilitate the assembly of the tissue anchor device 100.

1. Proximal Shaft

FIG. 7 is an exploded view of a tissue anchor device 100 that includesthe body 102 and distal tip 200 in an aspect. In this aspect, the distaltip 200 may include a proximal shaft 202 protruding in a proximaldirection. The proximal shaft 202 may be configured to fit within thedistal opening 138 of the body. In another aspect, the distal tip 200may further include a flange 204 with an outer diameter that is largerthan the diameter of the distal opening 138, thereby providing amechanical stop to limit the degree of insertion of the proximal shaft202 into the distal opening 138. In this other aspect, the body 102 maybe further provided with a distal face 140 against which the flange 204of the distal tip 200 may press when the body 102 and distal tip 200 areassembled to form the tissue anchor device 100 as illustrated in FIG. 8.In this aspect, the outer diameter of the flange 204 may be essentiallymatched to the outer diameter of the distal end 106 of the body 102,such that the body 102 an distal end 200 form a relatively smoothprofile when assembled, as illustrated in FIG. 9. In yet another aspect,the passage 116 within the body may include a step 142 which has asmaller dimension than the proximal shaft 202, within the passage 116inside the body 102 may also serve to stop the distal tip 200 fromsliding into the body 102.

Referring again to FIG. 8, the proximal shaft 202 of the distal tip 200may be press-fit into the distal opening 138 of the body 102. Withoutbeing limited to any particular theory, the forces on the tissue anchordevice 100 are typically applied in a proximal direction along thelongitudinal axis 118 of the tissue anchor device 100. Loads may beapplied to the distal tip 200 and may serve to further seat the proximalshaft 202 within the distal opening 138 of the body 102, therebymaintaining a secure coupling between the distal tip 200 and the body102 without the addition of any other materials or processing. In oneaspect, the coupling between the distal tip 200 and the body 102 may bea force fit or a friction fit. In other aspects, an adhesive or otherbiocompatible bonding agent or bonding process may be used to maintainor improve the coupling between the distal tip 200 and the body 102.

Referring again to FIG. 7, the distal tip 200 and the body 102 of thedistal opening 138 may further include mechanical elements (not shown)to maintain or improve the coupling between the distal tip 200 and thebody 102. Any known interlocking mechanical elements may be incorporatedinto the distal tip 200 and body 102 including, but not limited to,roughened surface textures, additional elements such as compressionwashers and the like, and interlocking mechanical elements such asmeshing threads. In one aspect, the outer surface 210 of the proximalshaft 202 and receiving surface 144 of the distal opening 138 mayinclude surface roughening (not shown). In another aspect, a compressionwasher or washer with a roughened texture (not shown) may be insertedover the proximal tip 202 prior to assembly of the tissue anchor device100. In an additional aspect, the outer surface 210 of the proximalshaft 202 may include a threaded portion (not shown) that may intermeshwith a threaded receptacle (not shown) formed on the receiving surface144 of the distal opening 138; the distal tip 200 may be rotated toadvance the threaded portion into the threaded receptacle of the distalopening 138. In another additional aspect, the outer surface 210 of theproximal shaft 202 may include one or more tabs or protrusions (notshown) that may intermesh with one or more tracks or slots (not shown)formed on the receiving surface 144 of the distal opening 138. In thisother additional aspect, the distal tip may be advanced into the distalopening 138 with the one or more tabs or protrusions upon the outersurface 210 of the proximal shaft 202 aligned with one or more gaps (notshown) formed in the one or more tracks or slots on the receivingsurface 144; the distal tip 200 may then be rotated a partial turn up toabout 45 degrees to advance the tabs or protrusions of the distal tip200 into the tracks or slots of the distal opening 138, thereby lockingthe distal tip 200 in place.

In various aspects, the distal tip 200 may be formed using any suitablebiocompatible material of sufficient strength without limitation. Invarious aspects, any one or more known materials for orthopedicfasteners may be used to construct the distal tip 200 including, but notlimited to: metals and alloys including stainless steel, titanium, andtitanium alloys, and biocompatible plastics and polymers such as PEEK.In one aspect, the distal tip 200 may be constructed of a singlematerial. In another aspect, the distal tip 200 may be a compositestructure composed of two or more materials. In yet another aspect, thedistal tip 200 and body 102 may be constructed of similar metalcompositions to prevent oxidation-reduction reactions between the body102 and distal tip 200 that may degrade one or both components overlong-term use.

2. Retention Features for Suture Exchange Fitting

Referring again to FIG. 8, the distal tip 200 may further include one ormore additional features to retain the suture exchange fitting 300 at adesired position and to further maintain the aperture 302 of the sutureexchange fitting 300 in an open position to facilitate the exchange ofsutures within the aperture 302. By way of non-limiting example, theseadditional features may include a distal recess 206 formed within thedistal end 208 of the distal tip 200 to secure the suture exchangefitting 300 in a fixed position near the distal end 106 of the body 102.Various aspects of additional features of the distal tip 200, as well asthe body 102, to retain the suture exchange fitting 300 are described indetail herein below.

c. Suture Exchange Fitting

Referring again to FIG. 2, the tissue anchor device 100 may furtherinclude a suture exchange fitting 300 with an aperture 302 in variousaspects. The aperture 302 may enable repair sutures to be shuttled orexchanged through the body 102 of the tissue anchor device 100 after thetissue anchor device 100 has been implanted in bone tissue and mayfurther enable the repair sutures to be passed through soft tissue inone aspect. In another aspect, the aperture 302 may be configured toremain fully open during each suture exchange, thereby maintaining thesuture friction and associated suture pulling force at acceptably lowlevels. Without being limited to any particular theory, a relativelyhigh suture friction and/or suture pulling force may degrade theeffectiveness of the tissue anchor device 100 due to reduction insurgical tactile feel during suture exchange and/or an inability toexecute the pull-through of sutures due to increased suture pullingforces. In another aspect, the aperture 302 of the suture exchangefitting 300 may be configured to close or collapse once the load ortension applied to the repair sutures exceed a particular thresholdcollapsing force, thereby preventing further suture exchanges.

During suture exchange and the initial passage of one or more repairsutures 110 through the soft tissue, the aperture 302 may maintain aspace sufficiently large to allow for the passage of up to severalsutures 110 through the body 102 of the tissue anchor device 100 afterimplantation in the bone tissue as described herein above. As describedherein below, each suture 110 exchanged through an aperture 302 may bedoubled over and as a result, the aperture 302 may be sized toaccommodate the unimpeded passage of 2 sutures for every desired sutureexchange. In one aspect, the aperture 302 may be sized to accommodate asingle suture exchange, corresponding to the passage of at least twosutures 110 simultaneously. In another aspect, the aperture 302 may besized to accommodate two suture exchanges concurrently, corresponding tothe passage of at least four sutures 110 simultaneously. In anadditional aspect, the aperture 302 may be sized to accommodate three ormore suture exchanges concurrently, corresponding to the passage of atleast six sutures 110 simultaneously.

In addition, the aperture 302 and associated suture exchange fitting 300may be provided with sufficient strength to withstand the pulling forcesthat are applied by the one or more repair sutures 110, therebymaintaining the space within the aperture 302 essentially unchangedthroughout the suture exchange process and fixation of a soft tissue toa bone tissue using the tissue anchor device 100. Non-limiting examplesof puling forces applied by the one or more repair sutures 110 duringthe exchange process include: tension resulting from pulling one or morerepair sutures and/or friction resulting from the sliding of the one ormore sutures through the aperture 302. In another aspect, additionaltension in the suture may result from pulling multiple sutures throughmultiple tissue layers and/or multiple tissue anchor devices 100 withmultiple apertures 302 during the course of an orthopedic repairprocedure as described herein below. In one aspect, the pulling forceapplied by the one or more repair sutures 110 during the exchange andrepair process may be less than about 20 lbs. In various other aspects,the pulling force may be less than about 19 lbs., less than about 18lbs., less than about 17 lbs., less than about 16 lbs., less than about15 lbs., less than about 14 lbs., less than about 13 lbs., less thanabout 12 lbs., less than about 11 lbs., less than about 10 lbs., lessthan about 8 lbs., less than about 4 lbs., or less than about 2 lbs.

During a suture exchange, the direction of sliding of the one or moresutures 110 may aligned at a variety of angles relative to the initialorientation of the sutures 110 and the aperture 302. Without beinglimited to any particular theory, a fixed suture exchange fitting 300that is unable to rotate may develop pinch points, suture cross-overtensions that may impede a suture exchange, and/or tortuosities that mayrestrict or prevent the completion of a suture exchange. In variousaspects, the aperture 302 and associated suture exchange fitting 300 maybe configured to rotate within a predetermined range during a sutureexchange due to torsion resulting from pulling one or more repairsutures 110 in a direction offset from a plane coincident with theaperture 302. Referring again to FIG. 2, the suture exchange fitting 300may include an exchange ring 304 defining the aperture 302 in oneaspect. In this aspect, the exchange ring 304 may be configured torotate and/or deform under torsional loads to maintain a sufficientlylarge aperture 302 for the suture exchange process. In another aspect,the exchange ring 304 and associated aperture 302 may consist of roundedshapes and edges to reduce the potential of binding, pinching, orotherwise impeding the sliding of one or more sutures 110 through theaperture 302 during a suture exchange. In this other aspect, theexchange ring 304 may be configured to include only internal angles ofgreater than about 90°. In one aspect, the exchange ring 304 may beprovided in an essentially semicircular shape, as illustrated in FIG. 2.

In an aspect, the predetermined range through which the exchange ring304 may rotate relative to an initial position of the exchange ring 304in the absence of a torsional load may be up to about 360°. In thisaspect, a rotation of the exchange ring 304 up to about 360° enables thesuture exchange fitting 300 to accommodate a variety of suture loads andmovements associated with a suture exchange and/or fixation of a softtissue to an underlying bone tissue, without collapse of the aperture302 and associated increase in pulling friction of the one or moresutures 110. Without being limited to any particular theory, it isthought that rotations of the exchange ring 304 to angles over 360°relative to the initial position of the exchange ring 304 may result incollapse of the aperture 302. In various other aspects, thepredetermined range through which the exchange ring 304 may rotaterelative to an initial position of the exchange ring 304 in the absenceof a torsional load may be up to about 360°, up to about 340°, up toabout 320°, up to about 300°, up to about 280°, up to about 260°, up toabout 200°, up to about 180°, up to about 150°, up to about 120°, up toabout 90°, up to about 45°, up to about 30°, and up to about 10°.

In various aspects, the exchange ring 304 may be constructed from anysuitable biocompatible material including, but not limited to: a metal,a plastic, or a suture or other flexible material including a wovenfabric or a braided fabric. In various other aspects, the exchange ring304 may also be provided in the form of a bar or clip machined or formedfrom a metal or plastic material. In these various other aspects, thebar or clip, when taken in combination with other features or structuresof the body 102 and/or distal tip 200, may define the aperture 302. Inan additional aspect, the aperture 302 may be machined, molded or formeddirectly into the body 102 and/or distal tip 200 of the tissue anchordevice 100.

In one aspect, the exchange ring 304 may be constructed from a flexiblematerial, thereby enabling the exchange ring 304 to deform through apredefined angular range during a suture exchange and/or fixation of asoft tissue to a bone tissue using the tissue anchor device 100. Inanother aspect, the suture exchange fitting 300 may be provided with arotational coupling to the body 102 and/or distal tip 200, therebyenabling the rotation of the exchange ring 304 without significantdeformation under torsional loads. In yet another aspect, the exchangering 304 may be provided with two or more rigid segments coupledtogether by one or more rotational couplings, thereby permitting atwisting movement of the two or more segments to accommodate torsionalloads while maintaining a sufficiently large aperture 302 during asuture exchange and/or fixation of a soft tissue to a bone tissue usingthe tissue anchor device 100. In various other aspects, any combinationof any of the features described herein above including, but not limitedto the flexible material, the rotational coupling, and/or the two ormore segments, may be incorporated into the suture exchange fitting 300.Detailed descriptions of the structure and function of specific sutureexchange fittings 300 in various aspects are provided herein below.

In various aspects, the aperture 302 of the suture exchange fitting 300may be configured to collapse, thereby essentially fixing the one ormore sutures 110 in place within the tissue anchor device 100 andcreating a more secure tissue fixation structure. FIG. 10 and FIG. 11are side views of a suture exchange fitting 300 with the aperture 302 inan open (FIG. 10) and collapsed (FIG. 11) configuration in an aspect.Referring to FIG. 10, once the suture exchange and the initial passageof one or more repair sutures 110 through the soft tissue is completed,a collapsing force 306 may be applied to the one or more sutures 110.This collapsing force 306 may be sufficiently high to collapse theaperture 302 into a collapsed configuration, as illustrated in FIG. 11.In one aspect, the collapsing force 306 applied by the one or morerepair sutures 110 after the exchange process may be greater than about20 lbs. In various other aspects, the collapsing force 306 may begreater than about 22 lbs., the collapsing force 306 may be greater thanabout 24 lbs., the collapsing force 306 may be greater than about 26lbs., the collapsing force 306 may be greater than about 28 lbs., thecollapsing force 306 may be greater than about 30 lbs., the collapsingforce 306 may be greater than about 35 lbs., the collapsing force 306may be greater than about 40 lbs., the collapsing force 306 may begreater than about 45 lbs., the collapsing force 306 may be greater thanabout 50 lbs., the collapsing force 306 may be greater than about 60lbs., the collapsing force 306 may be greater than about 70 lbs., thecollapsing force 306 may be greater than about 80 lbs., or thecollapsing force 306 may be greater than about 100 lbs.

1. Flexible Suture Exchange Fittings

In an aspect, at least a portion of the suture exchange fitting 300 maybe a flexible elongated element constructed from a flexible materialincluding, but not limited to, a suture material. Non-limiting examplesof suture materials suitable for inclusion in a suture exchange fitting300 include: non-absorbable suture materials such as polyethylene,polyester, and the like; absorbable suture materials such as alactide-glycolide copolymer and the like; and any combination thereof.In one aspect, the inclusion of flexible materials in the sutureexchange fitting 300 may enable the deformation of the suture exchangefitting 300 under torsional loads during suture exchange, as well as thecollapse of the aperture 302 under the collapsing force 306 as describedherein above.

FIG. 12 and FIG. 13 are side and top views, respectively, of a distaltip 200 with a suture exchange fitting 300 that has been deformed by atorsion resulting from the twisting of a suture 110 within the aperture302. In this aspect, the exchange ring 304 may be constructed of aflexible material, thereby enabling the deformation of the exchange ring304 from an initial position 304′ through a twist angle 308. Theexchange ring 304 may twist through a predetermined range as describedherein above including, but not limited to up to about 360°. In thisaspect, the predetermined range may be influenced by any one or more ofat least several factors, described herein below.

In one aspect, the structural integrity of the exchange ring 304 may besufficient to maintain the aperture 302 in an open position in thepresence of any forces and torques exerted on the exchange ring 304 byone or more sutures 110 in association with a suture exchange and/orfixation of a soft tissue to a bone tissue using the tissue anchordevice 100. In an aspect, the exchange ring 304 may resist deforming inresponse to a suture pulling force with a magnitude up to the collapsingforce as described herein above. In another aspect, the exchange ring304 may permit twisting within a predetermined angular range asdescribed herein above in response to a torsion exerted by the one ormore sutures 110 as described herein above. The structural integrity ofthe exchange ring 304 may be influenced by any one or more of at leastseveral factors including, but not limited to: the properties of thematerial used to construct the exchange ring such as tensile strengthand torsional stiffness, the dimensions of the exchange ring 304,additional support provided by the body 102 and/or distal tip 300, andthe reinforcement of at least a portion of the exchange ring 304.

In an aspect, the exchange ring 304 may be formed from a single braidedsuture. In other aspects, at least a portion of the exchange ring 304may be stiffened or shaped using an application of heat to adhere two ormore strands of the braided suture and/or through the application of acoating to the braided suture material. In additional aspect, a coatingapplied to the exchange ring 304 may further reduce the friction betweenthe exchange ring 304 and one or more sutures 110 sliding through theaperture 302 during a suture exchange or tightening of a suture duringfixation of a soft tissue to a bone tissue using the tissue anchordevice 100. In various other aspects, the exchange ring 304 may beconstructed from other materials including, but not limited to wire,monofilaments, metals, and the like. Non-limiting examples of suitablecoating materials include acrolytes, silicones; polyurethanes;polylactic acid; polyglycolic acid and other degradables; and fibringlue. In other aspects, the coating may be applied to a portion of theexchange ring 304 or to the entire exchange ring 304 as needed.

In an aspect, the structural integrity of the exchange ring 304 may beinfluenced by the dimensions of the exchange ring 304. FIG. 14 is a sideview of a distal tip and suture exchange fitting 300 with a relativelysmall aperture 302 in one aspect. FIG. 15 is a side view of a distal tipand suture exchange fitting 300 with a relatively large aperture 302 inanother aspect. In both aspects, the aperture size may be quantified byone or more dimensions of the aperture 302 including, but not limitedto, a maximum height 310, a maximum width 312, and an aperture area 314.

Referring again to FIG. 14 and FIG. 15, the maximum height 310 withrespect to the maximum width 312 of the exchange ring 304 may influencethe overall performance of the suture exchange. A relatively longermaximum height 310 (see FIG. 15) may increase the rotational flexibilityof the exchange ring 304; however, excessive maximum height 310 maypermit the ring exchange ring 304 to easily twist more than 360° whichmay effectively collapse the aperture 302, thereby hindering a sutureexchange. A relatively shorter maximum height 310 (see FIG. 14) maybetter resist twisting and collapse and thereby better maintain an openaperture compared to a taller exchange ring 304; however, if theexchange ring 304 is too short the aperture 302 may be too small toaccommodate the combined mass of all sutures 110 and may thereby hindera suture exchange.

In various aspects, the ratio of the maximum width 312 to the maximumheight of the aperture 310 may range from about 1:10 to about 3:1. Invarious other aspects, the ratio of the maximum width 312 to the maximumheight of the aperture 310 may range from about 1:10 to about 1:8, fromabout 1:9 to about 1:7, from about 1:8 to about 1:6, from about 1:7 toabout 1:5, from about 1:6 to about 1:4, from about 1:5 to about 1:3,from about 1:4 to about 1:2, from about 1:3 to about 1:1, from about 1:2to about 2:1, and from about 1:1 to about 3:1.

In an aspect, the aperture area 314 may be sufficient to accommodate asingle, double, or triple suture material mass, corresponding to asingle loaded, double loaded, or triple loaded tissue anchor device 100,respectively. In another aspect, the aperture area 314 may provideadditional space for a first suture to shift position relative to asecond suture. FIG. 16 is a side view of a triple-loaded suture exchangefitting 300 in which the aperture area 314 provides additional space fora first suture 110 to change positions relative to a second suture 110A.

i) First and Second Spaced-Apart Locations

In an aspect, the structural integrity of the suture exchange fitting300 may be enhanced by securing at least a portion of the sutureexchange fitting 300 to the body 102 and/or the distal tip 200 at afirst and second spaced-apart location. In this aspect, the securedportions of the suture exchange fitting 300 may be maintained inseparated positions, thereby maintaining the aperture 302 of the sutureexchange fitting 300 in an open position. FIG. 17 is a sidecross-sectional view of a tissue anchor device 100 in which the exchangering 304 of the suture exchange fitting 300 is secured within thepassage 116 of the body at a first spaced-apart location 146 and at asecond spaced-apart location 148. The first and second spaced-apartlocations 146/148 are typically positioned on opposite positions withinthe lumen 116 in order to maintain the aperture 302 in as wide-open aposition as possible within the lumen 116.

The exchange ring 304 of the suture exchange fitting 300 may be securedwithin the lumen 116 of the body 102 by any known means withoutlimitation. Referring again to FIG. 17, the inner wall 120 of the body102 may be provided with a pair of fixation fittings 150/152 throughwhich the exchange ring 304 may be threaded, thereby fixing the exchangering 304 at the first and second spaced-apart locations 146/148. Anysuitable fixation fitting may be used without limitation. In one aspect,the fixation fittings 150/152 may be a mechanical fitting including, butnot limited to: a ring (see FIG. 17), a hook, or a loop. In anotheraspect (not shown) the exchange ring 304 may be affixed to the innerwall 120 at the first and second spaced-apart locations 146/148 using abiocompatible adhesive. In yet another aspect (not shown) the exchangering 304 may be affixed by melting the inner wall 120 and/or portions ofthe exchange ring 304 at the first and second spaced-apart locations146/148. In various aspects, the fixation fittings 150/152 may beconfigured to release the secured portions of the exchange ring 304 whenthe exchange ring 304 is subjected to a collapsing force 306, to enablethe collapsing of the aperture 302 once a suture exchange through theexchange ring 304 is completed.

In other aspects, at least a portion of the exchange ring 304 may beaffixed at first and second spaced-apart locations 146/148 situated onthe distal tip 200 at a first and second side 212/214 in order tomaintain the aperture 302 in an open position. In these other aspects,the exchange ring 304 may be affixed to the distal tip 200 and then thedistal tip 200 may be inserted into the distal opening 138 of the body102. Once assembled, the exchange ring 304 is situated proximal to thedistal tip 200 within the passage 116 of the body 102, as illustrated inFIG. 2.

Referring to FIG. 18, the first and second side 212/214 of the distaltip 200 may be provided with a first and a second channel 216/218configured to hold at least a portion of the exchange ring 304 in oneaspect. The first and second channels 216/218 may be aligned with thelongitudinal axis 118 of the tissue anchor device 100 in an aspect. Inanother aspect, the first and second channels 216/218 may extend over atleast a portion of the distal tip 300.

Referring again to FIG. 7, the first and second channels 216/218 may begrooves extending the entire length of the distal tip 300. In thisaspect, the exchange ring 304 of the suture exchange fitting 300 may bewrapped around the distal tip 200 with portions of the exchange ringsituated within the first and second channels 216/218, as illustrated inFIG. 8; the exchange ring 304 may be wrapped around the distal tip 200before the distal tip 200 is pressed into the body 102. Once theproximal shaft 202 is inserted into the distal opening 138 of the body102, the portions of the exchange ring 304 are retained between thefirst and second channels 216/218 and the inner wall 120 of the distalopening 138. In this aspect, the distal tip 200 maintains the aperture302 of the exchange ring 300 in an open position and prevents theaperture 302 from collapsing.

FIG. 19 is a side cross-sectional view of an exchange ring 304constructed from a single piece of a flexible material including, butnot limited to a suture, in which the flexible material is affixed atthe first and second spaced-apart locations 146/148 in an aspect. Asillustrated in FIG. 19, the first and second spaced-apart locations146/148 may correspond to different sides of the distal tip 200 asdescribed herein previously. In this aspect, the flexible material mayinclude a first tail 316 situated between the flange 204 of the distaltip 200 and the distal face 140 of the body 102. The flexible materialmay further include a second tail 318 situated between the flange 204 ofthe distal tip 200 and the distal face 140 of the body 102 opposite tothe first tail 316. In this aspect, the first and second ends 318 may beheld in place by compressive forces between the distal tip 200 and thebody 102 as described herein previously. In another aspect, the flange204 and/or the distal face 140 may include additional features (notshown) to enhance the fixation of the first and second ends 316/318including, but not limited to: grooves or channels formed in the flange204 and/or distal face 140,

In another aspect (not illustrated), the first and second spaced-apartlocations 146/148 situated on the distal tip 200 may be provided in theform of a first lumen and a second lumen formed through the distal tip200. The first and second lumens may be aligned with the longitudinalaxis 118 of the tissue anchor device 100 and may open at the proximalshaft 202 and the distal end 208 of the distal tip 200. The first andsecond lumens may further be situated near the outer perimeter of thedistal tip 200 and located at opposite sides of the distal tip 200. Inthis other aspect, the exchange ring 304 may be formed from a singlelength of a flexible material as described herein previously, with thefirst tail 316 threaded through the first lumen and the second tail 318threaded through the second lumen. The first tail and the second tailmay be glued and/or melted within the first and second lumens. The firstand second tails may be threaded through the first and second lumens andthe distal ends of the first and second tails knotted to prevent thetails from retracting proximally through the lumens; each tail may beknotted separately, or the first and second tails may be knotted to oneanother.

FIG. 20 is a side view of a distal tip 200 and suture exchange fitting300 in an aspect. In this aspect, the exchange ring 304 may be createdby adhering the first tail 316 and the second tail 318 of a singlelength of a flexible material including, but not limited to, a suturesegment directly to the distal tip 200 at first and second spaced-apartlocations 146/148; the first and second tails 316/318 may also bedirectly overmolded into the distal tip 200 at the first and secondspaced-apart locations 146/148. In this aspect, the distal tip 200 maybe provided with a proximal face 220 to provide a surface suitable foradhering the first and second tails 316/318. In another aspect, theproximal face 220 may be provided with one or more fixation features(not shown) at the first and second spaced-apart locations 146/148 tofurther facilitate the adhesion of the first and second tails 316/318 tothe distal tip 200. Non-limiting examples of suitable fixation featuresinclude depressions, grooves, channels, bores, lumens, and raisedfeatures such as clips, hooks, and the like.

ii) Flexible Exchange Rings

In various aspects, the exchange ring 304 may be constructed from anysuitable flexible material without limitation. In one aspect, theexchange ring 304 may be constructed from standard suture. In anotheraspect, the suture may be a continuous ring including, but not limitedto a suture formed through a continuous braiding process. In this oneaspect, the first tail 316 and the second tail 318 may extend into oneanother in a continuous manner to form the continuous loop.

In another aspect, the suture may be a single piece ending in a firsttail 316 and a second tail 318. In this other aspect, the first tail 316and a second tail 318 may be secured to the body 102 and/or distal tip200 at a first spaced apart location 146 and at a second spaced-apartlocation, respectively, as described herein previously.

In yet another aspect, the first tail 316 and the second tail 318 of thesuture may be tied to one another in a knot to form the exchange ring304. Referring again to FIG. 7 and FIG. 8, the knot 320 may be situatednear the distal end 208 of the distal tip 200. In an aspect, the distalend 208 may include a feature to retain the knot 230 including, but notlimited to, a distal recess 206. In various aspects, the knot 320 may beone of any variety of suitable knots. However, the knot 320 may beconfigured to avoid undesirable stress concentrations in the suture thatmay result in a premature failure of the exchange ring 304, and may befurther configured to withstand any anticipated loads on the tissueanchor device 100 during prolonged use without slipping or untying.

In an aspect, the knot 320 may be reinforced to prevent slipping oruntying using any suitable knot reinforcement method. Non-limitingexamples of suitable knot reinforcement methods include: heating andmelting the first and second tails 316/318 of the knot 320, applying astiff material to the first and second tails 316/318 of the knot 320,and any combination thereof. In another aspect, the knot 320 may also beset and/or reinforced by heating and melting the outer surface 322 ofthe entire knot in order to stiffen the material without compromisingthe strength of the suture. In an additional aspect, an adhesive orother coating may be applied to the outer surface 322 of the knot 320 tostiffen and reinforce the knot 320. Non-limiting examples of suitableadhesives or other coatings include: polymers, epoxies, adhesives,plastics, and any combination thereof.

In an aspect, the stiffness of at least a portion of the exchange ring304 formed from a flexible material may be modified by the addition ofone or more reinforcement features. In one aspect, the flexible materialmay be heated and/or melted in one or more portions to stiffen the oneor more portions of the exchange ring 304. In another aspect, at least aportion of the flexible material may be coated, impregnated, and/orovermolded with adhesive or other coating material including, but notlimited to: polymers, epoxies, adhesives, plastics, and any combinationthereof. The stiffness of the supporting material can be controlled toallow the ring to collapse once a defined load has been reached.

In another aspect, the first tail 316 and the second tail 318 may bejoined by a joining member (not shown) configured to retain the firstand second tails 316/318, thereby forming the continuous ring. Thejoining member may be any suitable joining device including, but notlimited to: a splice, a clamp, and a joiner. The joining member may beconstructed from any suitable material including, but not limited to:metals, polymers, epoxies, adhesives, plastics, and any combinationthereof. The joining member may be affixed to the first and second tails316/318 by any suitable mechanism including, but not limited to:crimping, molding, twisting, advancing a clamp screw or set screw,repositioning a latch, and any other suitable mechanism. In an aspect,the joining member may be seated within a distal recess 206 formedwithin the distal tip 200 opposite to the distal end 208, as illustratedin FIG. 8.

In another aspect, the stiffness of at least a portion of the exchangering 304 formed from a flexible material may be stiffened by theincorporation of additional reinforcing elements. The additionalreinforcing elements may be incorporated at any portion of the exchangering 304 and may be attached, imbedded or otherwise incorporated asdescribed herein below. In various aspects, the one or more additionalreinforcing elements may be configured to fail upon exposure to a loadin excess of a collapsing force 306 to enable the collapsing of theaperture 102 and locking of the one or more sutures 110 within theaperture 102 after completion of a suture exchange.

FIG. 21 is a side view of an exchange ring 304 that includes a flexiblematerial and an external reinforcing element 322. In one aspect, theexternal reinforcing element 322 may be provided in the form of a sleevesituated over the top of the exchange ring 304, as illustrated in FIG.21. In another aspect, the external reinforcing element 322 may beprovided in the form of a U-shaped reinforcement structure situated onat least a portion of the inner surface of the exchange ring 304adjacent to the aperture 302, as illustrated in FIG. 22. In theseaspects, the external reinforcing element 322 may be constructed of anysuitably stiff and biocompatible material including, but not limited to:a polymer, a plastic, a metal, a suture sleeve, and any combinationthereof. This approach may also create a smooth bearing interface toallow a repair suture 110 to more easily slide through the aperture 302during an exchange process. To this end, the external reinforcingelement 322 may be constructed of a material characterized by arelatively low friction coefficient.

FIG. 23 is a side view of an exchange ring 304 that includes a flexiblematerial and an internal reinforcing element 324. In one aspect, theinternal reinforcing element 324 may be provided in the form of areinforcing insert 324 situated in a suture lumen 326. In one aspect,the top of the exchange ring 304. In this aspect, the externalreinforcing element 322 may be constructed of any suitably stiff andbiocompatible material including, but not limited to: a polymer, aplastic, a metal including NiTi, stainless steel, and/or titanium, andany combination thereof.

In various aspects, the stiffness of the reinforcing element 322/324 maybe modulated through a variety of means to allow the exchange ring 304to collapse once the collapsing force 306 has been exceeded after asuture exchange. The dimensions of the reinforcing element 322/324 maybe configured to create a region of high stress that may collapse uponexposure to a force in excess of the collapsing force 306. By way ofnon-limiting example, the reinforcing element 322/324 may include alocal thin or hollow region configured to fail, thereby enabling thecollapse of the exchange ring 304. The reinforcing element 322/324 maybe provided in the form of a composite element in which one or moreregions may be constructed from a weaker material configured topreferentially fail before the remainder of the reinforcing element322/324, thereby enabling the collapse of the exchange ring 304. Thereinforcing element 322/324 may further include one or more regions inwhich a portion of the material has been removed, including, but notlimited to defects, cutouts, gaps, and/or perforations. FIG. 24 is aside view of an internal reinforcing element that includes a defect 328configured to preferentially fail and collapse the exchange ring 304 atsufficiently high loads.

2. Rigid Suture Exchange Fittings

In various aspects, the exchange ring 304 may also be constructed fromany suitable rigid and biocompatible material without limitation.Non-limiting examples of suitable rigid materials include: polymers,plastics, metals including NiTi, stainless steels, and/or titanium andtitanium alloys, and any combination thereof. In one aspect, theexchange ring 304 may be constructed from a wire, a braided cable, acoated wire, a coated braided cable, a molded plastic, and any othersuitable rigid structure. In an aspect, the rigid material of theexchange ring 304 may provide a smooth bearing interface defining theaperture 302 to allow the repair suture 110 to more easily slide throughthe exchange ring 304 during the exchange process. Further, the rigidexchange ring 304 may be well-suited to maintain the aperture 302 in thepresence of various loads associated with a suture exchange. In anaspect, the stiffness of the rigid exchange ring 304 may be modulatedthrough a variety of means to allow the exchange ring 304 to collapseonce the collapsing force 306 has been exceeded after a suture exchange.The dimensions of the exchange ring 304 may be configured to create aregion of high stress that may collapse upon exposure to a force inexcess of the collapsing force 306. By way of non-limiting example, theexchange ring 304 may include a local thin or hollow region configuredto fail, thereby enabling the collapse of the exchange ring 304. Theexchange ring 304 may be provided in the form of a composite element inwhich one or more regions may be constructed from a weaker materialconfigured to preferentially fail before the remainder of the exchangering 304, thereby enabling its collapse. The exchange ring 304 mayfurther include one or more regions in which a portion of the materialhas been removed, including, but not limited to defects, cutouts, gaps,and/or perforations.

In one aspect, the rigid exchange ring 304 may be relatively limitedwith respect to the range of rotation of the aperture 102 enabled duringa suture exchange. In various other aspects, the suture exchange fixture200 may include additional features to enable the rotation of theexchange ring 304 within a predetermined range during a suture exchangeas described previously herein. These additional features may enablerotation of a rigid suture exchange fixture 200 within a limited range.Non-limiting examples of additional features include various cylindricalor spherical cavities formed within the passage 116 of the body and/orthe distal tip 200 that may interact with one or more features of thesuture exchange fitting 300 to enable the rotation of the aperture 302during a suture exchange. In another additional aspect, the rigidexchange ring 304 may include additional features to permit the exchangering 304 to freely swivel without limitation.

FIG. 50A, FIG. 50B and FIG. 50C are cutaway views of a tissue anchordevice 100 that include a free-swiveling rigid exchange ring 304 in oneaspect. Referring to FIG. 50A, the tissue anchor device 100 in thisaspect may include the exchange ring 304, positioned within the passage116 of the tissue anchor device 100. The exchange ring 304 may beconfigured to rotate or swivel freely with respect to the body 102 ofthe tissue anchor device 100. The swiveling functionality in this aspectdecouples the rotational orientation of the exchange ring 304 from therotational orientation of the body 102 of the tissue anchor device 100,thereby allowing the orientation of one or more sutures 110 threadedthrough the aperture 302 of exchange ring 304 in any desired directionwithout regard to the rotation of the body 102 of the tissue anchordevice 100.

FIG. 50A illustrates a cut-away view of the tissue anchor device 100that includes the free-swiveling exchange ring 304 in one aspect. Afirst rotational orientation of the body 102 is illustrated in FIG. 50A,with a body landmark 190 shown as a reference. The exchange ring 304 maybe positioned within the aperture 302 of body 102. As shown in FIG. 50A,the rigid exchange ring 304 may be retained via a flexible link 192 thatpermits essentially unlimited rotation about the screw axis.

In various aspects, the link 192 may be constructed from any suitableflexible material without limitation including, but not limited to, athread or suture material. The link 192 may be provided in any formwithout limitation including, but not limited to, a strip, a loop, aband, or any other suitable flexible form capable of enabling freerotation of the exchange ring 304. As illustrated in FIG. 50A, theflexible link 192 may be provided in the form of a suture or thread thatis doubled and looped through the aperture 302 of the exchange ring 304and passed through the distal opening 138 within the distal tip 200 ofthe tissue anchor device 100 in an aspect. In this aspect, the distalend 196 of the link 192 may terminate in a knot 194 or other suitablejoining or terminating structure to retain the distal end 196 outside ofthe distal tip 200, thereby providing a robust and swiveling attachmentof the exchange ring 304 to the body 102. The exchange ring 304 may beof a different structure or configuration than that shown in FIG. 50Athat allows free-swiveling movement relative to the body 102 of thetissue anchor device 100 without departing from the spirit of theinvention.

FIG. 50B is an illustration of the tissue anchor device 100 shown inFIG. 50A with the body 102 rotated at a 45° angle about the screw axisrelative to the orientation shown in FIG. 50A, as evidenced by thechange in orientation of the body landmark 190. As shown in FIG. 50B,while the body 102 of the tissue anchor device 100 is rotated at a 45°angle, the orientations of the exchange ring 304 and aperture 302, thelink 192, and the one or more sutures 110 are unchanged from theorientations illustrated in FIG. 50A.

FIG. 50C is an illustration of the tissue anchor device 100 shown inFIG. 50A with the body 102 rotated at a 90° angle about the screw axisrelative to the orientation shown in FIG. 50A, as evidenced by thechange in orientation of the body landmark 190. As shown in FIG. 50C,while the body 102 of the tissue anchor device 100 is rotated at a 90°angle, the orientations of the exchange ring 304 and aperture 302, thelink 192, and the one or more sutures 110 are unchanged from theorientations illustrated in FIG. 50A and FIG. 50B.

The decoupling of the rotational orientation of the exchange ring 304from those elements of the tissue anchor device 100 affixed within abone provides advantages that would be appreciated by those of skill inthe art. The exchange ring 304 may rotationally orient in a directionthat minimizes the tortuosity of the path traversed by the one or moresutures 110 threaded through the aperture 302 of the exchange ring 304.In contrast, a suture 110 loaded into a fixed thread-holding member (notshown) may become twisted when the suture anchor device (not shown) isdeployed and screwed into a bone. Without being limited to anyparticular theory, reducing the tortuosity of the suture's path mayreduce the amount of force required to exchange one or more sutures 110between one or more tissue anchor devices 100 as described herein.Swiveling may further allow a suture 110 threaded through an exchangering 304 to slide with minimal tortuosity when tensioning the suture 110within a particular repair construct as described herein below.

FIG. 25 is a cross-sectional side view of a tissue anchor device 100with a rigid exchange ring provided in the form of a bar or clip 330 inan aspect. In this aspect, the clip 330 may be contained within a cavity222 formed within the distal tip 200. The lower wall 224 of the cavitymay be relatively wide, thereby permitting the clip 330 to rotate withinthe cavity 222 during a suture exchange. In an aspect, the cavity 222may include an annular groove (not shown) formed in the lower wall 224within which the ends 332 of the clip 330 may slide to enable rotationof the aperture 302 during a suture exchange. In this aspect, theannular groove may extend around the entire circumference of the lowerwall 224, or the annular groove may extend over a portion of thecircumference of the lower wall 224 to constrain the rotation of theclip 330 to within a limited range. In this aspect, the upper wall 224may taper proximally from the relatively wide lower wall 224 to a narrowneck 230. During a suture exchange, the clip 330 may be subjected torelatively low pulling forces from the one or more sutures 110. Aftercompletion of the suture exchange, a pulling force in excess of thecollapsing force 306 may cause the clip 330 to deform into a collapsedclip 330′ in which the ends 332 of the clip 330′ are forced together bythe narrow diameter of the neck 230. In the collapsed configuration, theclip 330′ may entrap the one or more sutures 110, thereby preventing anyfurther sliding movements.

FIG. 26 is a cross-sectional side view of a tissue anchor device 100with a rigid exchange ring 304 provided in the form of a U-shaped clip330 in another aspect. In this other aspect, the U-shaped clip 330 maybe contained within a cavity 222 formed within the distal tip 200. Thewall 224 of the cavity 222 may be relatively wide, thereby permittingthe U-shaped clip 330 to rotate within the cavity 222 during a sutureexchange. In an aspect, the cavity 222 may include an annular groove(not shown) formed in the wall 224 within which the ends 332 of theU-shaped clip may slide to enable rotation of the aperture 302 during asuture exchange in a manner similar to the annular groove describedherein previously in connection with the suture exchange fitting 300 ofFIG. 25. In this aspect, the distal tip may further include a relativelynarrow neck 230 situated distally to the cavity 222. During a sutureexchange, the U-shaped clip in the open configuration is subjected torelatively low pulling forces from the one or more sutures 110 andfreely rotates within the cavity 222. After completion of the sutureexchange, the U-shaped clip may be pushed down distally into the neck230, thereby forcing the ends 332 of the clip 330 to deform into acollapsed clip 330′. In the collapsed configuration, the collapsed clip330′ may entrap the one or more sutures 110, thereby preventing anyfurther sliding movements. The ends 332 of the clip 330′ may includebarbs 333 that may retain the ends 332 within the cavity 222; thecollapsed clip 330′ may resist unlocking from the cavity 222 even whenthe repair sutures 110 are tensioned.

FIG. 27 is a cross-sectional side view of a tissue anchor device 100with an exchange ring 304 provided in the form of a rigid exchange ring304 in an additional aspect. In this additional aspect, the rigidexchange ring 304 may freely float within a cavity 222 formed within thetissue anchor device 100. In various aspects, the cavity 222 may beformed within the body 102 or within the distal tip 200 of the tissueanchor device 100. The rigid exchange ring 304 defines an aperture 302that is sufficiently large to allow for a suture exchange. The rigidexchange ring 304 may also to rotate with respect to the longitudinalaxis 118 of the tissue anchor device 100. In another aspect, the cavity222 may be provided with one or more ridges (not illustrated) or othermechanical stops to limit the rotation of the rigid exchange ring 304within a limited rotational range inside of the cavity 222. In anaspect, the ridges may be aligned parallel with the longitudinal axis118 of the tissue anchor device 100.

FIG. 28 is a cross-sectional side view of a tissue anchor device 100with an exchange ring 304 provided in the form of a bearing 334 inanother aspect. In this other aspect, the bearing 334 may be situated ina cavity 222 formed between the body 102 and within the distal tip 200of the tissue anchor device 100. In an aspect, the bearing 334 may beprovided as an essentially cylindrical bar with a circumferential groove336 or neck in the mid-section of the bearing 334. The bearing 334 maybe free to rotate about its own axis 338 which would ease a sutureexchange. The bearing 334 may also be free to rotate around thelongitudinal axis 118 of the tissue anchor device 100 to allow the oneor more repair sutures 110 (not shown) to self-align in the direction ofsuture tension. The groove 336 provides a guide for the one or moresutures 110 and prevents any sutures 110 from becoming pinched betweenthe inner wall 120 of the body 102 and the bearing 334. FIG. 29 is aperspective view of a disk-shaped bearing 334A with a groove 336 formedat the mid-section of the bearing 334A in another aspect.

FIG. 30 is a cross-sectional side view of a tissue anchor device 100with an exchange ring 304 provided in the form of a bearing 334B inanother aspect. In this other aspect, the bearing 334 may be situated ina cylindrical cavity 222 formed between the body 102 and within thedistal tip 200 of the tissue anchor device 100. In an aspect, thebearing 334B may be provided as a ring 340 with a transverse bar 342across the ring 340. FIG. 31 is a top view of the bearing 334B in thisaspect. The bearing 334B may be free to rotate about its own axis 338which would ease a suture exchange. The bearing 334 may also be free torotate around the longitudinal axis 118 of the tissue anchor device 100to allow the one or more repair sutures 110 (not shown) to self-align inthe direction of suture tension. The groove 336 provides a guide for theone or more sutures 110 and prevents any sutures 110 from becomingpinched between the inner wall 120 of the body 102 and the bearing 334.FIG. 31 is a perspective view of a disk-shaped bearing 334A with agroove 336 formed at the mid-section of the bearing 334A in anotheraspect.

FIG. 32 is a cross-sectional side view of a tissue anchor device 100with an exchange ring 304 attached to a shaft 344 provided with one ormore bearings 340/342 in another aspect. In this aspect, the exchangering 304 may be attached to a proximal end 346 of the shaft 344, and afirst bearing 340 may be attached to a distal end 348 of the shaft 344opposite to the proximal end 346. A second bearing 342 may also beattached to a middle portion of the shaft 344 between the exchange ring304 and the first bearing 340. The exchange ring 304 may be situatedwithin the passage 116, rendering the aperture 302 accessible to the oneor more sutures 110 via the proximal opening 108 of the body 102. Thefirst bearing 340 may be retained within a second cavity 232 formedwithin the distal end 200, and the second bearing 342 may be retainedwithin a cavity 222 formed between the distal end 106 of the body 102and the proximal shaft 202. The first bearing 340 and the second bearing342 may freely rotate about the longitudinal axis 118 of the tissueanchor device 100. The body 102 may have a narrow neck 230 defined at adistal end of the aperture 116 to entrain the shaft 344 between theexchange ring 304 and the second bearing 342. One or more sutures 110may be looped through the aperture 302 in this aspect.

FIG. 33 is a perspective view of a distal tip 200 in which a groove 234is formed in the proximal shaft 202 in an aspect. A bar 350 may beinserted across transverse to the groove 234 to form a suture exchangefitting 300. One or more sutures 110 may be inserted through an aperture302 formed between the bar 350 and the base 236 of the groove 234. Thebone anchor can be constructed such that it has a transverse break inthe proximal section of the body of the bone anchor to create a spacefor the suture exchange. The entire tip assembly may be attached to thebody 102 (not shown) via the distal opening 138. The distal tip 200 maybe configured to freely rotate about the longitudinal axis 118 of thetissue anchor device 100. FIG. 34 is a perspective view of a body 102within which a groove 154 is formed within the proximal end 104 of thebody 102 in an aspect. In this aspect, a bar 350 may be insertedtransversely across the groove 154. One or more sutures 110 may belooped through the aperture 302 formed between the bar 350 and the base156 of the groove 154.

In both of the aspects illustrated in FIG. 33 and FIG. 34, the bar 350may be provided in a variety of cross-sectional shapes and lengthwiseprofiles without limitation. In an aspect, the bar may be configured toprovide a low-friction suture exchange fitting 300 capable ofaccommodating a range of suture pulling forces and changes in thedirections of suture pulling forces associated with a suture exchangeand the fixation of a soft tissue to a bone tissue using the tissueanchor device 100. Non-limiting examples of suitable cross-sectionalshapes for the bar 350 include circular, elliptical, crescent-shaped andthe like. Non-limiting examples of suitable lengthwise profiles for thebar 350 include: linear, as illustrated in FIG. 33 and FIG. 34; andcurved including an arched, parabolar, and/or semi-circular lengthwiseprofile. In another aspect, the bar may 164 be provided with additionalfeatures including, but not limited to: local thinning of the bar 350cross-sectional dimension and/or notches, perforations and/or or otherdefects formed within at least a portion of the bar 350, and anycombination thereof to enable the collapse of the bar 350 into acollapsed configuration when the bar is subjected to a pulling force inexcess of a collapsing force as described herein previously.

FIG. 35 is a cross-sectional side view of a tissue anchor device 100with the suture exchange fitting 300 provided in the form of an exchangering 304 attached to a ball 352 that is pulled into a socket 156 formedat the distal opening 138 of the bone anchor body 102 or at the distalend 138 of the distal tip 200. The exchange ring 304 may consist of aprefabricated ring produced from a material including, but not limitedto, a metal, a polymer, a plastic, a suture, and the like. The exchangering 304 may be attached to the ball 352 using any method including, butnot limited to: overmolding the ball 352 onto a portion of the exchangering 304 and/or bonding the exchange ring 304 onto the ball 352 with abiocompatible adhesive. The ball 325 may be pulled from outside thedistal end 208 or distal opening 138 into the socket 156 by pulling in aproximal direction on the exchange ring 304 either directly or via oneor more sutures 110 looped through the aperture 302 within the exchangering 304. In an aspect, the ball 352 and socket 156 may be matched inprofile to enable the free rotation of the aperture about thelongitudinal axis 118 of the tissue anchor device 100.

d. Sutures

Referring again to FIG. 2, the tissue anchor device 100 may furtherinclude one or more sutures 110 looped through the suture exchangefitting 300 within the body 102 of the tissue anchor device 100. Eachsuture 110 may include a single loop situated at one end of the suture110, or two loops situated at opposite ends of the suture 110. In oneaspect, a suture 110 with a single loop may enable a suture exchange ina single direction (away from the single loop) whereas a suture with apair of loops may enable suture exchanges in two directions, therebyenhancing the range of functions potentially performed by the suture 110within the tissue anchor device 100. The one or more sutures 110 may beexchanged between different tissue anchor devices 100 (not shown) andmay be used to anchor a soft tissue to an underlying bone tissue asdescribed in further detail herein below. FIG. 36 is an illustration ofa suture 110 in one aspect. In this aspect, each suture 110 may includea main suture length 158 ending at a first suture loop 164 attached at afirst suture end 160 and a second suture loop 166 attached at a secondsuture end 162 opposite to the first suture end 160.

In various aspects, the suture loops 164/166 may act as snares toreversibly hold and guide the end of a second suture 172 as the secondsuture 172 is pulled through tissue and/or an aperture 302 of a tissueanchor device 100. FIG. 37 is a schematic view of an initial step in asuture exchange from a second tissue anchor device 100′ to a firsttissue anchor devices 100 in one aspect. In this aspect, a first sutureend 160′ and a first suture loop 164′ of a second suture 172 arethreaded through the first suture loop 164 of the first suture 170; thisthreading results in the second suture 172 being doubled over the firstloop 164 of the first suture 170. The second suture end 162 of the firstsuture 170 may then be pulled away from the first tissue anchor device100 to pull the second suture 172 through the first tissue anchor device100. FIG. 38 is a schematic illustration of a subsequent stage of thesuture exchange shown in FIG. 37. As illustrated in FIG. 38, the firstloop 164 and doubled over second suture 172 have been pulled through theaperture 302 (not shown) of the first tissue anchor device 100,resulting in the second suture 172 being threaded through both the firsttissue anchor device 100 and the second tissue anchor device 100′. Thesecond suture 172 may now be pulled at both the first suture end 160′and the second suture end 162′ to compress the soft tissue 402 againstthe underlying bone tissue 404.

In various aspects, the sutures 110 may be constructed of any suitablesuture material without limitation. In an aspect, the sutures may beconstructed of a material including, but not limited to: a monofilament,a tubular suture material, a braided suture material, and anycombination thereof. Non-limiting examples of suture materials suitablefor inclusion in a suture exchange fitting 300 include: non-absorbablesuture materials such as polyethylene, polyester, Nylon, Cortex, Silk,polyvinylidene fluoride, polyvinylidene fluoride-co-hexafluoropropylene,Poly (ethylene, terephthalate), stainless steel and the like; absorbablesuture materials such as a lactide-glycolide copolymer, polyglactin,monocryl, polyester poly(p-dioxanone), and panacryl and the like; andany combination thereof. In one aspect, the inclusion of flexiblematerials in the suture exchange fitting 300 may enable the deformationof the suture exchange fitting 300 under torsional loads during sutureexchange, as well as the collapse of the aperture 302 under thecollapsing force 306 as described herein above.

In various aspects, the size of the sutures 110 may be any size for usein an orthopedic surgical procedure consistent with the use of thetissue anchor device 100 without limitation. In one aspect, the suturediameter may range from about 0.02 mm (USP #10-0) to about 0.8 mm (USP#4). In other aspects, the suture diameters may range from about 0.02 mmto about 0.06 mm, from about 0.04 mm to about 0.08 mm, from about 0.06mm to about 0.10 mm, from about 0.08 mm to about 0.12 mm, from about0.10 mm to about 0.14 mm, from about 0.12 mm to about 0.16 mm, fromabout 0.14 mm to about 0.18 mm, from about 0.16 mm to about 0.20 mm,from about 0.18 mm to about 0.22 mm, from about 0.20 mm to about 0.30mm, from about 0.25 mm to about 0.35 mm, from about 0.30 mm to about0.40 mm, from about 0.35 mm to about 0.45 mm, from about 0.40 mm toabout 0.50 mm, from about 0.45 mm to about 0.55 mm, from about 0.50 mmto about 0.60 mm, from about 0.55 mm to about 0.65 mm, from about 0.60mm to about 0.70 mm, from about 0.65 mm to about 0.75 mm, from about0.70 mm to about 0.80 mm, Non-limiting examples of suitable suturediameters include: USP #10-0 (0.02 mm), USP #9-0 (0.03 mm), USP #8-0(0.04 mm), USP #7-0 (0.05 mm), USP #6-0 (0.07 mm), USP #5-0 (0.10 mm),USP #4-0 (0.15 mm), USP #3-0 (0.20 mm), USP #2-0 (0.30 mm), USP #0 (0.35mm), USP #1 (0.40 mm), USP #2 (0.50 mm), USP #3 (0.60 mm), USP #5 (0.70mm), and USP #6 (0.8 mm).

In various other aspects, the sutures 110 may have an overall lengthranging from about 2.5 cm to about 70 cm. In additional aspects, thesutures 110 may have an overall length ranging from about 2.5 cm toabout 10 cm, from about 5 cm to about 15 cm, from about 10 cm to about20 cm, from about 15 cm to about 25 cm, from about 20 cm to about 30 cm,from about 25 cm to about 35 cm, from about 30 cm to about 40 cm, fromabout 35 cm to about 45 cm, from about 40 cm to about 60 cm, and fromabout 50 cm to about 70 cm.

Referring again to FIG. 36, the one or more sutures 110 may have sutureloops 164/166 at opposite ends 160/162 of the suture 110. In an aspect,the dual suture loops 164/166 enable the suture 110 to be pulled towardthe first suture end and/or the second suture end 162 as needed in thecourse of a surgical procedure. The double suture loops 164/166 enablesuture pull-through in any direction, change of direction,multiple-anchor utilization, after insertion of the tissue anchor device100, during post-insertion linkage changes, and during a remedialsurgical procedure including, but not limited to reverse a repair and/orchanging a method of linkage.

In an aspect, the first and second loops suture loops 164/166 may beconfigured to pull a second suture 172 through a soft tissue and/or anaperture 302 within a tissue anchor device 100. As a consequence, thestrength of the first and second suture loops 164/166 may be less thanthe tensile strength of the main suture length 158, which may besubjected to relatively higher tensions in order to affix a soft tissueto an underlying bone tissue. In another aspect, the first and secondloops suture loops 164/166 may be configured to reduce the suturetension associated with pulling the second suture 172 and optionally oneor more additional attached sutures 110′ through the soft tissue and/oraperture 302. In this other aspect, the first and second loops sutureloops 164/166 may be constructed with a low profile configurationincluding one or more of at least several features including, but notlimited to: relatively low suture diameter, compact collapsed size,smooth transition between the suture end 160/162 and the correspondingsuture loop 164/166.

In one aspect, the first and second loops suture loops 164/166 may beconstructed of the same suture material as the main suture length 158.In this aspect, the loops 164/166 may be formed by forming a loop at thefirst and second suture ends 160/162 and attaching each suture tip toits respective suture end 160/162. The tips may be attached by anysuitable means including, but not limited to: continuous braiding of theloop, biocompatible adhesive, melting/welding, and any combinationthereof. In another aspect, the first and second loops suture loops164/166 may be constructed of a different or smaller-diameter materialrelative to the main suture length 158. In this other aspect, thematerial used to construct the first and second loops suture loops164/166 may reduce the overall size of the loops in a collapsedconfiguration, thereby reducing pulling force during a suture change.

FIG. 39 is top view of a first suture loop 164 formed by a bifurcation168 of the main suture length 158 at the first suture end 164 in oneaspect. In this aspect, the distal portion of the loop 164 may rejoin toform a full-diameter loop tip 174. In this aspect, the loop 164 may besecurely attached to the suture end 160 by virtue of the continuity ofsuture material between the main suture length 158 and the loop 164. Inaddition, the transition from the suture end 160 to the loop 164 issmooth, thereby reducing the pulling friction associated with passingthe loop through a soft tissue and/or aperture 304. As the loop 160 ispulled through a soft tissue or aperture, the loop 160 may collapse to acompact size approaching that of the main suture length in this aspect.

In various aspects, the diameter of each loop 164/166 may be configuredto accommodate the suture exchange of one or more sutures 110 in oneaspect. In this aspect, the loop diameter may be at least 1 mm. In otheraspects, smaller or larger sutures may be used and the loop sizediameter may decrease or increase accordingly. In additional aspects,the loop diameter may be at least 1 mm, at least 2 mm, at least 3 mm, atleast 4 mm, at least 5 mm, at least 6 mm, at least 7 mm, at least 8 mm,at least 9 mm, at least 10 mm, or at least 20 mm. In other aspects, thediameter of each loop 164/166 may be configured to provide a suitablegrip for a surgeon's hand or a surgical tool manipulated by a surgeon,or the loop diameter may be configured to simplify the act of loadingsuture ends 160/162 into the loop 164/166. In these other aspects, thediameter of each loop may be larger than the diameter that accommodatesthe suture exchange of one or more sutures 110.

In an additional aspect, at least a portion of the suture loops 164/166and/or the main suture length 158 in close proximity to the suture loops164/166 may be stiffened to facilitate the loading of additional sutures110 into the suture loops 164/166, to facilitate the loading of thesuture 110 by threading the suture loops 164/166 through an aperture 302within a tissue anchor device 100, to provide tactile feedback to thesurgeon, and any combination thereof. In one aspect, the loops 164/166may be stiffened to maintain the loops 164/166 in a collapsedconfiguration, resulting in a smaller profile during use. In anotheraspect, the loops 164/166 may be stiffened to maintain the loops 164/166in an opened configuration, thereby facilitating the loading ofadditional sutures 110 into the loops 164/166 and/or to provide a largerprofile for a surgeon to grip during use. In various aspects, the loops164/166 may be stiffened using any suitable method including, but notlimited to heat setting, application of stiffening coatings including,but not limited to a polymer or resin coating, and any combinationthereof. However, it is to be noted that the stiffening loops 164/166may retain the ability to collapse during passage through an aperture304 or tissue without unduly high suture pulling forces that may disruptthe smooth pull of the sutures 110 during a surgical procedureassociated with good tactile feedback to the surgeon.

II. Surgical Kit

In an aspect, the tissue anchor device 100 described herein above may beincluded in a surgical kit for use by a surgeon in a surgical procedure.FIG. 40 is a block diagram summarizing the components of the surgicalkit 500 in one aspect. The surgical kit 500 may include the tissueanchor device 100 described herein above, including at least one suture110. The surgical kit may further provide instructions 502 and adelivery device 504.

In various aspects, the instructions 502 may be provided by any suitablemeans including, but not limited to: printed on packaging enclosing atleast some of the surgical kit 500; enclosed within packaging enclosingat least some of the surgical kit 500; accompanying the surgical kit500; published as an electronic communication such as an e-mail;published on an internet website; and any combination thereof. Invarious aspects, the instructions 502 may include information associatedwith the assembly of the tissue anchor device 100, informationassociated with implantation of the tissue anchor device 100,information associated with using the tissue anchor device 100 in anorthopedic surgical procedure, and any other information relevant to theassembly and use of the tissue anchor device 100. In this aspect,information associated with the assembly of the tissue anchor device 100may include guidance for threading the at least one suture 110 throughthe aperture 302 of the suture exchange fitting 300, passing the firstand second suture ends 160/162 proximally through the passage 116 of thebody 102 and out the proximal opening 108, joining the distal tip 200 tothe body 102 by inserting the proximal shaft 202 of the distal tip intothe distal opening 138 of the body 102, and any combination thereof. Inthis aspect, information associated with the implantation of the tissueanchor device 100 in an orthopedic surgical procedure may includeguidance for coupling the delivery tool 504 to the tissue anchor device100 and delivering a torque to drive the tissue anchor device 100 intothe bone tissue. In this aspect, information associated with using thetissue anchor device 100 in an orthopedic surgical procedure may includeguidance for exchanging one or more sutures 110 between one or moreapertures 302 associated with different tissue anchor devices 100 toenable various surgical procedures including, but not limited toassembling and securing one or more suture patterns suitable forattaching a soft tissue to a bone tissue.

The delivery device 504 may be any driver system suitable for orthopedicfasteners without limitation. Non-limiting examples of suitable deliverydevices 504 include: single-slot driver systems, star-shaped driversystems, cruciform driver systems, Phillips driver systems, hexagonaldriver systems and any other suitable driver system.

III. Method of Anchoring Soft Tissue

In various aspects, one or more tissue anchor devices 100 may be used toanchor a soft tissue to a bone. The one or more tissue anchor devices100 may be implanted in a bone and linked to one another afterimplantation via one or more sutures without the use of a knot or otherinter-anchor fixation, thereby establishing a contiguous inter-anchorsuture ending at a pair of free suture ends. Each suture end is attachedto a first anchor device 100 and a last anchor device 100′. The freesuture ends may be used for any generally accepted final repair fixationpractice, including, but not limited to, anchor fixation, knotlessanchor fixation, knot fixation, or linkage to additional anchor devices100″.

In one aspect, an orthopedic repair including fixation of a soft tissueto a bone may use at least two tissue anchor devices 100 and at leastone suture 110. The suture 110 may be passed through the at least two atleast two tissue anchor devices 100 using a suture exchange methoddescribed in detail herein below. Using one or more suture exchanges, asingle suture 110 may form a single continuous span or linkage of suturebetween the at least two tissue anchor devices 100. The singlecontinuous suture span may end in two free ends that may be used toimplement a final fixation or knot in accordance with standard surgicalsuture fixation practices and products.

In this aspect, the use of a single suture provides at least severalbenefits over existing knotted linkage techniques. The use of a singlesuture and at least two tissue anchor devices 100 as a linkage enablessuperior adhesion of the soft tissue to the bone compared to a knottedlinkage. The use of the at least two tissue anchor devices 100 providesthe capability to use a “running stich” of suture 110 for a faster andsimplified repair. Because the suture 110 is not fixed at each anchor100, the suture 110 is capable of sliding to a limited degree betweenanchor points, thereby efficiently distributing the compression loadover the soft tissue. Using this method, the suture tension and stressmay also be distributed across multiple anchors 100, thereby reducingthe likelihood of developing single failure points in which all tensionand stress may be isolated to a single anchor. The use of this methodfurther enables the implementation of at least several suture patternsas needed, thereby enhancing the options available to the surgeon andthe resulting effectiveness of the surgical procedure.

FIG. 41 is a flow chart summarizing a method of anchoring a soft tissueto a bone using the tissue anchor device 100 described herein above inone aspect. The method may include assembling the tissue anchor device100 at step 602. In one aspect, the tissue anchor device 100 may beassembled by causing the distal tip 200 that is loaded with a firstsuture 110A to be received in the distal opening 138 of the body 102such that the first suture 170 extends through the passage 116 of thebody 102 and out the proximal opening 108 such that the first and secondends 160/162 of the first suture 170 extend proximally from the proximalopening 108.

Referring again to FIG. 41, the method may further include attaching adelivery device 504 to the tissue anchor device 100 at step 604. In oneaspect, the first suture 170 may be extended through a lumen of thedelivery device 504 such that the first and second ends 160/162 of thefirst suture 170 extend proximally from a proximal end of the deliverydevice 504 and a distal end of the delivery device 504 is coupled with aproximal end 104 of the body 102, the lumen extending between a distalend of the delivery device 504 and the proximal end of the deliverydevice 504. The coupled delivery device 504 may be used to torque thefirst tissue anchor into the bone at step 606. In one aspect, thedelivery device 504 may apply a torque to the body 102 via the distalend of the delivery device 504 coupled to the tool fitting 134 formedwithin the proximal opening 108 as described herein above.

Referring again to FIG. 41, the tissue anchor device 100 may beimplanted into the bone at step 608. In one aspect, a bore may bepreformed within the bone prior to implanting the tissue anchor device100. In another aspect, if the external thread 114 of the body 102includes a self-tapping feature, the tissue anchor device 100 may beinserted without need to form a bore beforehand. In one aspect, thetissue anchor device 100 may be implanted by advancing the body 102 anddistal tip 200 into the bone until the proximal end 104 of the body 102is essentially level with the exposed surface of the bone. In anotheraspect, if the suture exchange fitting 300 is situated proximally to theproximal end 104 of the body 102, the body and the distal tip 200 may beadvanced into the bone until the proximal end 104 of the body 102 isdistal relative to the exposed surface of the bone.

The method 600 may further include extending the first and second ends160/162 of the first suture 170 through the soft tissue at step 610. Thesoft tissue may be any soft tissue to be reattached to a bone including,but not limited to, a tendon and/or a ligament. In an aspect, the firstand second ends 160/162 of the first suture 170 may be extended throughone or more layers, each layer including a soft tissue to be attached tothe bone. A second suture 172 may be extended through a first loop 164defined at the first end 160 of the first suture 170. FIG. 37 is anillustrating showing the second suture 172 extended through the firstloop 164 of the first suture 170. As illustrated in FIG. 37, the firstend 160′ of the second suture 172 may now extend proximally from asecond tissue anchor device 100′ and the second end 162′ of the secondsuture 172 may extend proximally through a soft tissue 402.

In various aspects, variations of the method 600 may be used toimplement a variety of suture patterns and techniques as needed toenhance the linkage between the soft tissue 402 and the bone 404.Non-limiting examples of suture patterns and techniques include: asingle suture box stitch pattern, a lateral medial bridge stitch patternusing a knotless single suture, a medial bridge, inter-implant mattressstitch pattern, a train track, a parallel horizontal repair using 2anchors, and a medial dam suture pattern to block synovial fluidinfiltration. Additional description of the suture patterns andtechniques are provided herein below.

FIG. 42A, FIG. 42B, FIG. 42C, FIG. 42D, FIG. 42E, and FIG. 42Fillustrate schematically a single row repair accomplished using animplanted first anchor 100 with a first suture 170 and an implantedsecond anchor 100′ with a second suture 172. The first and secondanchors 170/172 may be implanted as illustrated in FIG. 42A. Referringto FIG. 42B, a suture exchange may be started by threading the secondend B2 of the second suture 172 through the second end A2 of the firstsuture 170. As illustrated in FIG. 42C, the exchange of the secondsuture 172 into the first anchor 100 is completed by pulling on thefirst end A1 of the first suture 170. The first suture 170 may then beremoved from the second suture 172, as illustrated in FIG. 42D. The endsB1/B2 of the second suture 172 may then be tensioned as illustrated inFIG. 42E. The ends B1/B2 of the second suture 172 may then be joinedusing a knot or a knotless joiner 176 as illustrated in FIG. 42E.

FIG. 43A, FIG. 43B, FIG. 43C, FIG. 43D, FIG. 43E, FIG. 43F, and FIG. 43Gillustrate schematically a wide single row repair accomplished using animplanted first anchor 100 with a first suture 170 and an implantedsecond anchor 100′ with a second suture 172. The first and secondanchors 170/172 may be implanted as illustrated in FIG. 43A. Referringto FIG. 43B, the suture ends A1/A2 and B1/B2 may be pulled through thesoft tissue layer at widely separated locations. Referring to FIG. 43C,a suture exchange may be started by threading the second end B2 of thesecond suture 172 through the first end A1 of the first suture 170. Asillustrated in FIG. 43D, the exchange of the second suture 172 into thefirst anchor 100 is completed by pulling on the first end A2 of thefirst suture 170. The second suture may be pulled through both widelyseparated locations in the soft tissue near the first anchor 170 asillustrated in FIG. 43D. The first suture 170 may then be removed fromthe second suture 172 to complete the suture exchange, as illustrated inFIG. 43E. The ends B1/B2 of the second suture 172 may then be tensionedas illustrated in FIG. 43F. The ends B1/B2 of the second suture 172 maythen be joined using a knot or a knotless joiner 176 as illustrated inFIG. 43G.

FIG. 44A, FIG. 44B, FIG. 44C, FIG. 44D, FIG. 44E, FIG. 44F, and FIG. 44Gillustrate schematically a double row repair accomplished usingimplanted single-loaded anchors 100A, 100B, 100C, and 100D. The anchors100A, 100B, 100C, and 100D may be implanted in a square pattern asillustrated in FIG. 44A and both ends of each suture may be pulledthrough the soft tissue over each corresponding anchor. Referring toFIG. 44B, a suture exchange may be started by threading the first end A1through the first end C1 and pulling on the second end C2. Asillustrated in FIG. 44C, the exchange of suture end A1 through anchor110C may be completed by pulling on the suture end C2. Similar sutureexchanges may be further accomplished to pull suture end A2 throughanchor 100B as illustrated in FIG. 4D and suture end A1 through anchor100D, as illustrated in FIG. 44E. The first suture 170 may then beremoved from the second suture 172 to complete the suture exchange, asillustrated in FIG. 44E. The ends A1/A2 may then be tensioned asillustrated in FIG. 44F. The ends A1/A2 may then be joined using a knotor a knotless joiner 176 as illustrated in FIG. 44G.

FIG. 45A, FIG. 45B, FIG. 45C, FIG. 45D, FIG. 45E, FIG. 45F, and FIG. 45Gillustrate schematically a double row repair accomplished usingimplanted double-loaded anchors 100A, 100B, 100C, and 100D. The anchors100A, 100B may be implanted as illustrated in FIG. 45A and both ends ofeach suture may be pulled through the soft tissue over eachcorresponding anchor. Referring to FIG. 45B, a suture exchange may beaccomplished by threading the suture end B3 through the suture end A3and pulling on the opposite suture end A4. Referring to FIG. 45C, asuture exchange may be accomplished by threading the suture end B1through the suture end A2 and pulling on the opposite suture end A1. Asillustrated in FIG. 45D, the additional double-loaded anchors 100C and100D may be implanted, resulting in a square anchor pattern. Referringto FIG. 45E, the exchange of suture ends B1 and B2 through anchor 110Cmay be completed similarly using the two loaded sutures of anchor 100C.Referring to FIG. 45F, the exchange of suture ends B3 and B4 throughanchor 110D may be completed similarly using the two loaded sutures ofanchor 100D. The ends A1, A2, B1, and B2 may then be tensioned andjoined using a knot or a knotless joiner 176 as illustrated in FIG. 45G.

FIG. 46A, FIG. 46B, FIG. 46C, FIG. 46D, FIG. 46E, FIG. 46F, and FIG. 46Gillustrate schematically a transosseous repair accomplished usingimplanted double-loaded anchors 100A, 100B, 100C, and 100D. The anchors100A, 100B may be implanted as illustrated in FIG. 46A and both ends ofeach suture may be pulled through the soft tissue situated over eachcorresponding anchor. Referring to FIG. 46B, a suture exchange may beaccomplished by threading the suture end B3 through the suture end A3and pulling on the opposite suture end A4. Referring to FIG. 46C, asuture exchange may be accomplished by threading the suture end B1through the suture end A2 and pulling on the opposite suture end A1. Asillustrated in FIG. 46D, the additional double-loaded anchors 100C and100D may be implanted in a different bone or at an offset location notcovered by the soft tissue layer, resulting in a square anchor pattern.Referring to FIG. 46E, the exchange of suture ends B1 and B2 throughanchor 110C may be completed similarly using the two loaded sutures ofanchor 100C, and the exchange of suture ends B3 and B4 through anchor110D may be completed similarly using the two loaded sutures of anchor100D. Referring to FIG. 46F, the suture ends A1, A2, B1, and B2 may betensioned and retained knotlessly within corresponding anchors 100C and100D. Alternatively, the ends A1, A2, B1, and B2 may then be tensionedand joined using a knot or a knotless joiner 176 as illustrated in FIG.46G.

FIG. 47A and FIG. 47B are schematic illustrations of additionalarrangements of sutures and anchors associated with double row repairsillustrated in FIG. 44G and FIG. 45G, respectively. FIG. 47A illustratesa double-row repair accomplished using implanted single-loaded anchors100A, 100B, 100C and 100D. As illustrated in FIG, 47A, the ends of thesingle continuous suture 170 may be crossed over and secured within apair of implanted knotless anchors 110E and 100F. FIG. 47B illustrates adouble-row repair accomplished using implanted double-loaded anchors100A, 100B, 100C and 100D. As illustrated in FIG, 47B, the ends of afirst single continuous suture 170 may be crossed over and securedwithin a pair of implanted knotless anchors 110E and 100F, and the endsof a second single continuous suture 172 may be secured within the pairof implanted knotless anchors 110E and 100F without crossing over.

FIG. 48A, FIG. 48B, FIG. 48C, and FIG. 48D illustrate schematically atraditional bridged repair accomplished using implanted double-loadedanchors 100A, 100B, 100C, and 100D. The anchors 100A, 100B may beimplanted as illustrated in FIG. 48A and both ends of each suture may bepulled through the soft tissue over each corresponding anchor. Referringto FIG. 48B, a suture exchange may be accomplished by threading thesuture end B1 through the suture end A3 and pulling on the oppositesuture end A4. Referring to FIG. 48C, suture ends B1 and B2 may betensioned and joined with a knot. As illustrated in FIG. 48D, theadditional double-loaded anchors 100C and 100D may be implanted,resulting in a square anchor pattern. Referring again to FIG. 48D, theexchange of suture ends A1 and B3 through anchor 110C and the exchangeof suture ends A2 and B4 through anchor 110D may be completed similarlyusing the pairs of sutures loaded on anchors 100C and 100D. Referring toFIG. 48E, the ends A1, A2, B3, and B4 may be tensioned and secured usinga single knotless anchor 100E. Referring to FIG. 48F, the suture ends A1and B3 may be secured using knotless anchor 100C, and suture ends A2 andB4 may be tensioned and secured using knotless anchor 100D.

FIG. 49A, FIG. 49B, FIG. 49C, FIG. 49D, FIG. 49E, FIG. 49F, FIG. 49G,FIG. 49H, FIG. 49I, and FIG. 49J illustrate schematically repair of alabrum tear accomplished using implanted double-loaded anchors 100A,100B, 100C, and 100D. The anchors 100A, 100B, 100C, and 100D may beimplanted within a glenoid bone 180 as illustrated in FIG. 49A, and theopposite ends of each suture may be situated at opposite sides of theoverlying labrum tissue 178. Referring to FIG. 49B and 49G, a sutureexchange of suture end A2 between anchor 100A and anchor 100B may beaccomplished using one of the two sutures threaded through anchor 100B.Referring to FIG. 49C and FIG. 49H, the suture end A2 may be threadedsuccessively through anchors 100B, 100C, and 100D in a spiral patternusing one of the loaded sutures in each corresponding anchor. Asillustrated in FIG. 49H, the suture end A2 passes over the labrum 180between successive anchors and passes under the labrum 180 as the sutureend A2 passes through each successive anchor. As illustrated in FIG. 49Dand FIG. 49I, the suture end A2 may be exchanged from anchor 100D toanchor 100C using the remaining loaded suture in anchor 100C. Referringto FIG. 49E and FIG. 49J, the suture end A2 may be threaded successivelythrough anchors 100B, 100C, and 100D in a spiral pattern using theremaining loaded suture in each corresponding anchor. As illustrated inFIG. 49J, the suture end A2 passes over the labrum 180 betweensuccessive anchors and passes under the labrum 180 as the suture end A2passes through each successive anchor; the direction of crossing isopposite to the direction illustrated in FIG. 49H, resulting in acrossed suture pattern around the labrum 180. Referring to FIG. 49F, thesuture ends A1 and A2 may be tensioned and secured with a knot orknotless joiner.

The foregoing merely illustrates the principles of the invention.Various modifications and alterations to the described embodiments willbe apparent to those skilled in the art in view of the teachings herein.It will thus be appreciated that those skilled in the art will be ableto devise numerous systems, arrangements and methods which, although notexplicitly shown or described herein, embody the principles of theinvention and are thus within the spirit and scope of the presentinvention. From the above description and drawings, it will beunderstood by those of ordinary skill in the art that the particularembodiments shown and described are for purposes of illustrations onlyand are not intended to limit the scope of the present invention.References to details of particular embodiments are not intended tolimit the scope of the invention.

What is claimed is:
 1. A tissue anchor comprising: a body comprising aproximal end, a distal end opposite the proximal end, a proximal openingat the proximal end, a distal opening at the distal end, and a passageextending longitudinally through the body between the proximal anddistal openings; and a flexible elongated element at least contributingto the defining of an aperture that opens in a direction substantiallyperpendicular to a longitudinal axis of the passage, the flexibleelongated element being secured to the body at first and secondspaced-apart locations facilitating the aperture being maintained in anopen condition.
 2. The tissue anchor of claim 1, wherein the first andsecond spaced-apart locations includes a first side of the passage and asecond side of the passage opposite the first side of the passage. 3.The tissue anchor of claim 2, wherein the flexible elongated element issecured to the each side of the passage via a ring, hook or loop.
 4. Thetissue anchor of claim 2, wherein the body further comprises a distaltip that is at least one of received or configured to be received in thedistal opening, and the first and second spaced-apart locations includea first side of the distal tip and a second side of the distal tipopposite the first side of the distal tip.
 5. The tissue anchor of claim1, wherein the body further comprises a distal tip that is at least oneof received or configured to be received in the distal opening, theflexible elongated element comprising a first tail and a second tailspaced-apart from the first tail by the first tail and the second tailrespectively intersecting the distal tip at the first and secondspaced-apart locations thereby facilitating the aperture beingmaintained in the open condition.
 6. The tissue anchor of claim 5,wherein, when the distal tip is received in the distal opening, theaperture is located in the passage proximal the distal tip.
 7. Thetissue anchor of claim 5, wherein the distal tip comprises a moldedmaterial and a distal region of the first tail and a distal region ofthe second tail are molded into the molded material at the first andsecond spaced-apart locations.
 8. The tissue anchor of claim 5, whereinthe distal tip is configured such that implantation forces exerted onthe distal tip enhance the extent to which the distal tip is received inthe distal opening.
 9. The tissue anchor of claim 5, wherein the firstand second spaced-apart locations respectively comprise first and secondspaced-apart channels in the distal tip, and a distal region of thefirst tail and a distal region of the second tail are respectivelylocated in the first and second spaced-apart channels.
 10. The tissueanchor of claim 9, wherein the first spaced-apart channel comprises agroove defined in an outer surface of the distal tip and the distalregion of the first tail extends through the groove, which opens againstan inner wall surface defining the passage when the distal tip isreceived in the distal opening.
 11. The tissue anchor of claim 9,wherein the first spaced-apart channel comprises a lumen defined in thedistal tip and the distal region of the first tail extends through thelumen.
 12. The tissue anchor of claim 9, wherein the first and secondtails are distally joined together via a knot.
 13. The tissue anchor ofclaim 11, wherein the knot is coated or impregnated with a polymer,epoxy or adhesive.
 14. The tissue anchor of claim 9, wherein the firstand second tails are part of a continuous loop of the flexible elongatedelement, the first and second tails extending into each other in acontinuous manner.
 15. The tissue anchor of claim 9, wherein the firstand second tails are distally joined together via a joining memberextending about the at least portions of the first and second tails. 16.The tissue anchor of claim 15, wherein the joining member is at leastone of crimped or molded onto the first and second tails.
 17. The tissueanchor of claim 16, wherein the distal tip comprises a distal recess inwhich the joining member is seated.
 18. The tissue anchor of claim 17,wherein the distal tip comprises a proximal shaft opposite the distalrecess, the distal tip being received in the distal opening on accountof the proximal shaft being received in the distal opening and residingin the passage.
 19. The tissue anchor of claim 18, wherein the proximalshaft forms an interference fit with at least one of the distal openingor the passage.
 20. The tissue anchor of claim 18, wherein the first andsecond spaced-apart channels extend longitudinally along the proximalshaft.
 21. The tissue anchor of claim 18, wherein the aperture isdefined between the flexible elongated element and a proximal end of theproximal shaft of the distal tip.
 22. The tissue anchor of claim 5,wherein a maximum height of the aperture in a non-deflected state andextending parallel to the longitudinal axis of the passage is definedbetween the flexible elongated element and a proximal end of the distaltip, and the maximum height of the aperture is between a height of theproximal end of the tissue anchor and a height of the proximal end ofthe body plus a thickness of a soft tissue, the soft tissue proximal tothe proximal end of the body.
 23. The tissue anchor as in any of claim 2or 5, in which a maximum width of the aperture in a non-deflected stateis defined between the first and second spaced-apart locations, and themaximum width of the aperture is approximately the maximum width of thepassage, the maximum width of the aperture extending perpendicular tothe longitudinal axis of the passage.
 24. The tissue anchor as in any ofclaim 2 or 5, in which a most proximal extent of the flexible elongatedelement in a non-deflected state is recessed distally within the passagefrom the proximal opening up to approximately a thickness of a suturemass to be passed through the aperture.
 25. The tissue anchor as in anyof claim 2 or 5, in which the proximal opening is configured tointerface with an insertion tool.
 26. The tissue anchor as in any ofclaim 2 or 5, in which the flexible elongated element comprises asuture.
 27. The tissue anchor of claim 26, wherein the suture is abraided suture formed of a material comprising polyethylene, thematerial further comprising a thickness of between approximately 0.008″and approximately 0.045″.
 28. The tissue anchor of claim 26, wherein thesuture is at least one of heat treated, coated or impregnated to atleast one of stiffen or shape the suture.
 29. The tissue anchor as inany of claim 2 or 5, in which the flexible elongated element comprises awire or monofilament.
 30. The tissue anchor as in any of claim 2 or 5,in which the flexible elongated element extends through a sheath. 31.The tissue anchor as in any of claim 2 or 5, in which the flexibleelongated element extends along a U-shaped channel member.
 32. Thetissue anchor as in any of claim 2 or 5, in which a segment of polymeror metal extends through a lumen of the flexible elongated element. 33.The tissue anchor of claim 5, wherein a loop encircles a portion of thedistal tip, the loop comprising the flexible elongated element, theaperture being defined between the flexible elongated element and aproximal end of the distal tip.
 34. The tissue anchor of claim 33,wherein the loop further comprises a joining member joining together thefirst and second tails of the flexible elongated element, and thejoining member is received in a distal recess of the distal tip.
 35. Thetissue anchor of claim 5, wherein the tissue anchor is a result of anassembly process comprising: a) assembling a tip assembly by causing aloop to encircle a portion of the distal tip, the loop comprising theflexible elongated element; and b) causing the tip assembly to bereceived in the distal opening of the body.
 36. The tissue anchor ofclaim 35, wherein the loop further comprises a joining member joiningtogether the first and second tails of the flexible elongated element,and the joining member is received in a distal recess of the distal tipas part of assembling the tip assembly.
 37. The tissue anchor of claim1, wherein the body further comprises a thread helically extending aboutan exterior of the body.
 38. The tissue anchor of claim 37, wherein thethread comprises a double helix thread comprising two distinct threadsoffset approximately 180 degrees from each other.
 39. The tissue anchorof claim 1, wherein the aperture has a minimum width to height ratio ofthree to one and a maximum width to height ratio of one to ten.
 40. Thetissue anchor of claim 1, wherein the flexible elongated element isconfigured to flex in a twisting rotation manner such that the aperturecan accommodate different suture exchange attack angles.
 41. The tissueanchor of claim 1, wherein the flexible elongated element is configuredto flex in a twisting rotation manner such that a direction in which theaperture opens when the flexible elongated element is at maximum twistedrotation is between approximately 90 degrees and approximately 360degrees from the direction in which the aperture opens when the flexibleelongated element is in a non-deflected state.
 42. The tissue anchor ofclaim 41, wherein the flexible elongated element is configured tomaintain the aperture sufficiently open to accommodate suture exchangedespite being at the maximum twisted rotation.
 43. The tissue anchor ofclaim 1, wherein the flexible elongated element is configured to flex ina twisting rotation manner such that the aperture has no angles that aretighter than approximately 90 degrees when the flexible elongatedelement is at a twisted rotation of up to approximately 90 degrees fromthe direction in which the aperture opens when the flexible elongatedelement is in a non-deflected state.
 44. The tissue anchor of claim 1,wherein the aperture is configured to accommodate a minimum massthroughput of 4 sutures.